Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
Summary
The FDA issued a Class I for Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF by ARROW INTERNATIONAL Inc.. Reason: Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health conseque.
Details
Source
Device Recall
External ID
Z-1879-2024
Action Date
2024-06-12
Status
Ongoing
Category
device
Product Description
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
Lot/Code Info: a) REF IAB-06830-U, UDI: (01)10801902161939(17)240731(10)18F22H0008, (01)10801902161939(17)241130(10)18F22M0019, (01)10801902161939(17)241231(10)18F23A0027, (01)10801902161939(17)241231(10)18F23A0039, (01)10801902161939(17)250131(10)18F23B0006, (01)10801902161939(17)250131(10)18F23B0020, (01)10801902161939(17)250131(10)18F23B0032, (01)10801902161939(17)250630(10)18F23G0066, (01)10801902161939(17)250731(10)18F23H0059, (01)10801902161939(17)250731(10)18F23H0070, (01)10801902161939(17)250731(10)18F23H0074, (01)10801902161939(17)250831(10)18F23J0046, (01)10801902161939(17)250930(10)18F23K0059, (01)10801902161939(17)251231(10)18F24A0036, (01)10801902161939(17)260331(10)18F24D0004, (01)10801902172898(17)240430(10)18F22E0062, (01)10801902172898(17)240531(10)18F22F0007, (01)10801902172898(17)240531(10)18F22F0017, (01)10801902172898(17)240531(10)18F22F0020, (01)10801902172898(17)240531(10)18F22F0034, (01)10801902172898(17)240531(10)18F22F0045, (01)10801902172898(17)240531(10)18F22F0057, (01)10801902172898(17)240630(10)18F22G0001, (01)10801902172898(17)240630(10)18F22G0004, (01)10801902172898(17)240630(10)18F22G0007, (01)10801902172898(17)240630(10)18F22G0014, (01)10801902172898(17)240731(10)18F22H0002, (01)10801902172898(17)240731(10)18F22H0024, (01)10801902172898(17)240731(10)18F22H0029, (01)10801902172898(17)240731(10)18F22H0034, (01)10801902172898(17)240831(10)18F22J0009, (01)10801902172898(17)250430(10)18F23D0029, (01)10801902172898(17)250430(10)18F23E0037, (01)10801902172898(17)250430(10)18F23E0038, (01)10801902172898(17)250531(10)18F23E0033, (01)10801902172898(17)250531(10)18F23E0057, (01)10801902172898(17)250531(10)18F23F0023, (01)10801902172898(17)250531(10)18F23F0045, (01)10801902172898(17)250630(10)18F23G0025, (01)10801902172898(17)250630(10)18F23G0026, (01)10801902172898(17)250630(10)18F23G0051, (01)10801902172898(17)250731(10)18F23G0067, (01)10801902172898(17)250731(10)18F23H0009, (01)10801902172898(17)250731(10)18F23H0025, (01)10801902172898(17)250731(10)18F23H0028, (01)10801902172898(17)250731(10)18F23H0069, (01)10801902172898(17)250731(10)18F23H0080, (01)10801902172898(17)250831(10)18F23H0011, (01)10801902172898(17)250831(10)18F23J0004, (01)10801902172898(17)250831(10)18F23J0011, (01)10801902172898(17)250831(10)18F23J0015, (01)10801902172898(17)250831(10)18F23J0053, (01)10801902172898(17)250831(10)18F23J0054, (01)10801902172898(17)250831(10)18F23J0055, (01)10801902172898(17)250930(10)18F23J0079, (01)10801902172898(17)250930(10)18F23K0003, (01)10801902172898(17)250930(10)18F23K0005, (01)10801902172898(17)250930(10)18F23K0009, (01)10801902172898(17)250930(10)18F23K0051, (01)10801902172898(17)250930(10)18F23K0061, (01)10801902172898(17)251031(10)18F23L0040, (01)10801902172898(17)251130(10)18F23M0002, (01)10801902172898(17)251130(10)18F23M0044, (01)10801902172898(17)251130(10)18F23M0049, (01)10801902172898(17)251130(10)18F23M0053, (01)10801902172898(17)251130(10)18F23M0054, (01)10801902172898(17)251231(10)18F23M0055, (01)10801902172898(17)251231(10)18F24A0006, (01)10801902172898(17)251231(10)18F24A0012, (01)10801902172898(17)251231(10)18F24A0013, (01)10801902172898(17)251231(10)18F24A0021, (01)10801902172898(17)260131(10)18F24B0014, (01)10801902172898(17)260228(10)18F24C0004, (01)10801902172898(17)260228(10)18F24C0005, (01)10801902172898(17)260331(10)18F24D0033, (01)10801902172898(17)260331(10)18F24D0036, (01)10801902172898(17)260331(10)18F24D0043, (01)10801902172898(17)260331(10)18F24D0048, (01)10801902172898(17)260331(10)18F24D0086; b) REF IAB-06840-U, UDI: (01)10801902161946(17)240430(10)18F22E0023, (01)10801902161946(17)240531(10)18F22F0009, (01)10801902161946(17)240531(10)18F22F0019, (01)10801902161946(17)240731(10)18F22H0014, (01)10801902161946(17)240731(10)18F22H0028, (01)10801902161946(17)240731(10)18F22H0036, (01)10801902161946(17)241130(10)18F22M0015, (01)10801902161946(17)241231(10)18F23A0019, (01)10801902161946(17)241231(10)18F23A0037, (01)10801902161946(17)241231(10)18F23A0054, (01)10801902161946(17)241231(10)18F23A0055, (01)10801902161946(17)241231(10)18F23A0061, (01)10801902161946(17)250131(10)18F23A0066, (01)10801902161946(17)250131(10)18F23A0067, (01)10801902161946(17)250228(10)18F23A0025, (01)10801902161946(17)250228(10)18F23B0018, (01)10801902161946(17)250331(10)18F23D0018, (01)10801902161946(17)250430(10)18F23E0013, (01)10801902161946(17)250430(10)18F23E0015, (01)10801902161946(17)250630(10)18F23G0002, (01)10801902161946(17)250630(10)18F23G0003, (01)10801902161946(17)250630(10)18F23G0011, (01)10801902161946(17)250731(10)18F23G0063, (01)10801902161946(17)250731(10)18F23H0034, (01)10801902161946(17)250731(10)18F23H0035, (01)10801902161946(17)250731(10)18F23H0038, (01)10801902161946(17)250731(10)18F23H0053, (01)10801902161946(17)250731(10)18F23H0058, (01)10801902161946(17)250731(10)18F23H0071, (01)10801902161946(17)250831(10)18F23J0006, (01)10801902161946(17)250831(10)18F23J0008, (01)10801902161946(17)250831(10)18F23J0014, (01)10801902161946(17)250831(10)18F23J0018, (01)10801902161946(17)250831(10)18F23J0035, (01)10801902161946(17)250831(10)18F23J0042, (01)10801902161946(17)250930(10)18F23K0028, (01)10801902161946(17)260131(10)18F24B0025, (01)10801902161946(17)260131(10)18F24B0026, (01)10801902161946(17)260228(10)18F24C0151, (01)10801902161946(17)260331(10)18F24C0171, (01)10801902161946(17)260331(10)18F24C0177, (01)10801902161946(17)260331(10)18F24C0178, (01)10801902161946(17)260331(10)18F24C0179, (01)10801902161946(17)260331(10)18F24C0180, (01)10801902161946(17)260331(10)18F24C0195, (01)10801902161946(17)260331(10)18F24D0014, (01)10801902161946(17)260331(10)18F24D0017, (01)10801902161946(17)260331(10)18F24D0030, (01)10801902172904(17)240430(10)18F22E0001, (01)10801902172904(17)240430(10)18F22E0009, (01)10801902172904(17)240430(10)18F22E0014, (01)10801902172904(17)240430(10)18F22E0020, (01)10801902172904(17)240430(10)18F22E0036, (01)10801902172904(17)240430(10)18F22E0037, (01)10801902172904(17)240430(10)18F22E0042, (01)10801902172904(17)240430(10)18F22E0046, (01)10801902172904(17)240430(10)18F22E0048, (01)10801902172904(17)240430(10)18F22E0049, (01)10801902172904(17)240430(10)18F22E0061, (01)10801902172904(17)240430(10)18F22E0065, (01)10801902172904(17)240430(10)18F22E0066, (01)10801902172904(17)240531(10)18F22F0002, (01)10801902172904(17)240531(10)18F22F0010, (01)10801902172904(17)240531(10)18F22F0016, (01)10801902172904(17)240531(10)18F22F0021, (01)10801902172904(17)240531(10)18F22F0022, (01)10801902172904(17)240531(10)18F22F0037, (01)10801902172904(17)240531(10)18F22F0043, (01)10801902172904(17)240531(10)18F22F0047, (01)10801902172904(17)240531(10)18F22F0050, (01)10801902172904(17)240531(10)18F22F0051, (01)10801902172904(17)240531(10)18F22F0054, (01)10801902172904(17)240531(10)18F22F0065, (01)10801902172904(17)240531(10)18F22F0066, (01)10801902172904(17)240531(10)18F22F0067, (01)10801902172904(17)240531(10)18F22H0026, (01)10801902172904(17)240630(10)18F22G0067, (01)10801902172904(17)240731(10)18F22H0004, (01)10801902172904(17)240731(10)18F22H0010, (01)10801902172904(17)240731(10)18F22H0030, (01)10801902172904(17)240731(10)18F22H0038, (01)10801902172904(17)240731(10)18F22H0039, (01)10801902172904(17)240930(10)18F22K0004, (01)10801902172904(17)250228(10)18F23C0017, (01)10801902172904(17)250228(10)18F23C0027, (01)10801902172904(17)250228(10)18F23C0044, (01)10801902172904(17)250331(10)18F23D0015, (01)10801902172904(17)250331(10)18R23G0002, (01)10801902172904(17)250430(10)18F23D0027, (01)10801902172904(17)250430(10)18F23D0028, (01)10801902172904(17)250430(10)18F23E0014, (01)10801902172904(17)250430(10)18F23E0028, (01)10801902172904(17)250430(10)18F23E0035, (01)10801902172904(17)250430(10)18F23E0036, (01)10801902172904(17)250430(10)18F23E0050, (01)10801902172904(17)250430(10)18F23E0051, (01)10801902172904(17)250430(10)18F23E0052, (01)10801902172904(17)250531(10)18F23E0055, (01)10801902172904(17)250531(10)18F23F0003, (01)10801902172904(17)250531(10)18F23F0006, (01)10801902172904(17)250531(10)18F23F0007, (01)10801902172904(17)250531(10)18F23F0014, (01)10801902172904(17)250531(10)18F23F0015, (01)10801902172904(17)250531(10)18F23F0024, (01)10801902172904(17)250531(10)18F23F0025, (01)10801902172904(17)250531(10)18F23F0048, (01)10801902172904(17)250531(10)18F23F0052, (01)10801902172904(17)250531(10)18F23F0054, (01)10801902172904(17)250531(10)18F23F0059, (01)10801902172904(17)250630(10)18F23G0005, (01)10801902172904(17)250630(10)18F23G0007, (01)10801902172904(17)250630(10)18F23G0014, (01)10801902172904(17)250630(10)18F23G0028, (01)10801902172904(17)250630(10)18F23G0050, (01)10801902172904(17)250630(10)18F23G0053, (01)10801902172904(17)250731(10)18F23G0064, (01)10801902172904(17)250731(10)18F23G0065, (01)10801902172904(17)250731(10)18F23H0057, (01)10801902172904(17)250731(10)18F23H0075, (01)10801902172904(17)250831(10)18F23H0033, (01)10801902172904(17)250831(10)18F23J0019, (01)10801902172904(17)250831(10)18F23J0041, (01)10801902172904(17)250831(10)18F23J0050, (01)10801902172904(17)250930(10)18F23K0017, (01)10801902172904(17)250930(10)18F23K0018, (01)10801902172904(17)250930(10)18F23K0019, (01)10801902172904(17)250930(10)18F23K0027, (01)10801902172904(17)250930(10)18F23K0040, (01)10801902172904(17)250930(10)18F23K0045, (01)10801902172904(17)250930(10)18F23K0057, (01)10801902172904(17)251031(10)18F23K0060, (01)10801902172904(17)251031(10)18F23L0006, (01)10801902172904(17)251031(10)18F23L0029, (01)10801902172904(17)251031(10)18F23L0030, (01)10801902172904(17)251130(10)18F23M0019, (01)10801902172904(17)251130(10)18F23M0020, (01)10801902172904(17)251130(10)18F23M0037, (01)10801902172904(17)251130(10)18F23M0039, (01)10801902172904(17)251130(10)18F23M0040, (01)10801902172904(17)251130(10)18F23M0041, (01)10801902172904(17)251231(10)18F23M0064, (01)10801902172904(17)251231(10)18F23M0065, (01)10801902172904(17)251231(10)18F24A0002, (01)10801902172904(17)251231(10)18F24A0003, (01)10801902172904(17)251231(10)18F24A0004, (01)10801902172904(17)251231(10)18F24A0005, (01)10801902172904(17)251231(10)18F24A0014, (01)10801902172904(17)251231(10)18F24A0016, (01)10801902172904(17)251231(10)18F24A0022, (01)10801902172904(17)251231(10)18F24A0023, (01)10801902172904(17)251231(10)18F24A0024, (01)10801902172904(17)251231(10)18F24A0038, (01)10801902172904(17)260131(10)18F24B0006, (01)10801902172904(17)260131(10)18F24B0007, (01)10801902172904(17)260131(10)18F24B0023, (01)10801902172904(17)260131(10)18F24B0024, (01)10801902172904(17)260131(10)18F24B0027, (01)10801902172904(17)260131(10)18F24B0028, (01)10801902172904(17)260131(10)18F24B0045, (01)10801902172904(17)260131(10)18F24B0046, (01)10801902172904(17)260131(10)18F24B0047, (01)10801902172904(17)260131(10)18F24B0068, (01)10801902172904(17)260131(10)18F24B0069, (01)10801902172904(17)260228(10)18F24B0067, (01)10801902172904(17)260228(10)18F24B0070, (01)10801902172904(17)260228(10)18F24B0071, (01)10801902172904(17)260228(10)18F24C0006, (01)10801902172904(17)260228(10)18F24C0007, (01)10801902172904(17)260228(10)18F24C0028, (01)10801902172904(17)260228(10)18F24C0029, (01)10801902172904(17)260228(10)18F24C0030, (01)10801902172904(17)260228(10)18F24C0038, (01)10801902172904(17)260228(10)18F24C0092, (01)10801902172904(17)260228(10)18F24C0120, (01)10801902172904(17)260228(10)18F24C0121, (01)10801902172904(17)260228(10)18F24C0141; c) REF IAB-06850-U, UDI: (01)10801902144192(17)240831(10)18F22J0020(13)220916, (01)10801902144192(17)240831(10)18F22J0038(13)220928, (01)10801902144192(17)240831(10)18F22J0043(13)220930, (01)10801902144192(17)240930(10)18F22K0001(13)221003, (01)10801902144192(17)240930(10)18F22K0003(13)221004, (01)10801902144192(17)240930(10)18F22K0006(13)221006, (01)10801902144192(17)240930(10)18F22K0011(13)221007, (01)10801902144192(17)240930(10)18F22K0012(13)221007, (01)10801902144192(17)240930(10)18F22K0013(13)221007, (01)10801902144192(17)241231(10)18F23A0075(13)230131, (01)10801902144192(17)250131(10)18F23B0005(13)230203, (01)10801902144192(17)250131(10)18F23B0010(13)230206, (01)10801902144192(17)250131(10)18F23B0029(13)230220, (01)10801902144192(17)250131(10)18F23B0030(13)230220, (01)10801902144192(17)250228(10)18F23C0007(13)230307, (01)10801902144192(17)250228(10)18F23C0008(13)230307, (01)10801902144192(17)250228(10)18F23C0014(13)230310, (01)10801902144192(17)250228(10)18F23C0015(13)230310, (01)10801902144192(17)250531(10)18F23F0016(13)230609, (01)10801902144192(17)250531(10)18F23F0017(13)230609, (01)10801902144192(17)250831(10)18F23J0043(13)230921, (01)10801902144192(17)250831(10)18F23J0044(13)230923, (01)10801902144192(17)250930(10)18F23J0078(13)231031, (01)10801902144192(17)250930(10)18F23K0015(13)231031, (01)10801902144192(17)250930(10)18F23K0024(13)231014, (01)10801902144192(17)251031(10)18F23L0045(13)231130, (01)10801902144192(17)251130(10)18F23L0052(13)231205, (01)10801902144192(17)251130(10)18F23L0058(13)231205, (01)10801902144192(17)260131(10)18F24B0011(13)240209, (01)10801902144192(17)260131(10)18F24B0012(13)240209, (01)10801902172911(17)250831(10)18F23H0061(13)230911, (01)10801902172911(17)260131(10)18F24B0010(13)240207
Quantity Affected: 44,807 units
Reason for Recall
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.
Distribution
Worldwide distribution. US nationwide including Puerto Rico, AU, BA, BE, BG, BN, CA, CL, CN, CO, CY, CZ, DE, EC, ES, FR, GB, GP, GR, HU, HK, IE, IL, IN, IQ, IT, JO, JP, KW, KZ, LB, LU, MA, MN, MK, MX, MY, NL, OM, PA, PF, PH, PL, PT, QA, RE, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, UZ, ZA, and UAE.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-29
Company
Morrisville, NC
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 212 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ARROW INTERNATIONAL Inc. has 55 FDA actions in our database, including 55 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ARROW INTERNATIONAL Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ARROW INTERNATIONAL Inc. have FDA actions?
ARROW INTERNATIONAL Inc. has 55 FDA actions in our database, including 55 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1879-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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