Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Cod
Summary
The FDA issued a Class I for Impella catheters - Intravascular micro axial blood pumps that support a patient by Abiomed, Inc.. Reason: IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator han.
Details
Source
Device Recall
External ID
Z-0980-2024
Action Date
2024-02-21
Status
Ongoing
Category
device
Product Description
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 1000080 and 0048-0045 - Impella CP with SmartAssist ***Updated February 2024*** (10) 004413 - Impella 2.5 Set (12) 0046-0026 - Impella 5.0 Pump Set ROW (13) 0046-0037 - Impella 5.0 Pump Set APAC (15) 004680-AU - 5.0 Pump Set AU (16) 0048-0002 - Impella CP Pump Set, EU (17) 0048-0002-BR - Impella CP Pump Set BR (18) 0048-0004 - Impella CP Pump Set, Canada (19) 0048-0014 - Impella CP Smart Assist Set, EU (20) 0048-0024-JP - Impella CP Smart Assist Set, JP (21) 0048-0044 - Impella CP Smart Assist Set, Canada (22) 0048-0047 - Impella CP Smart Assist Set APAC (23) 005040 - Impella 2.5 IMC Pump Set EU (24) 005048-JP - Impella 2.5 Pump Set, Japan (25) 005060 - Impella 5.0 IMC Pump Set EU (26) 005064 - Impella 5.0 IMC Pump Set Canada (27) 005066-JP - Impella 5.0 Pump Set, Japan (28) 0550-0002 - Impella 5.5 with SmartAssist Set, EU (29) 0550-0004 - Impella 5.5 with SmartAssist Set, CA (30) 1000115 - Impella CP Pump set, APAC (31) 1000211 - Impella 5.5 SmartAssist Set, JP (32) 1000302 - Impella CP with SmartAssist APAC (33) 1000361 - Impella 5.5 Set AU (34) 1000402 - Impella CP Smart Assist Set ***Updated March 15, 2024*** The following products were removed from the list of affected products because the Right-side devices are not in the scope of the warning to avoid left ventricle perforation: (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with SmartAssist (6) Product Code 1000323 - RP Flex with SmartAssist (11) 0046-0011 - Impella RP Pump Set, EU (14) 0046-0039 - Impella RP Set APAC
Lot/Code Info: UDI-DI (1) 00813502011081 (2) 00813502011180 (3) 00813502011227 (7) 00813502011531 and 00813502012828 (8) 00813502011388 (9) 00813502012279 and 00813502011876 All product IFUs include the Update ***Added February 2024*** (10) 813502010947 (12) 813502011821 (13) 813502011937 (15) N/A (16) 4260113630242 (17) 813502011777 (18) 813502011265 (19) 4260113630280 (20) 813502011609 (21) 813502012200 (22) 813502011944 (23) 4260113630136 (24) 813502010046 (25) 4260113630174 (26) 813502011197 (27) 813502010053 (28) 813502011630 (29) 813502010466 (30) 813502010473 (31) 813502012453 (32) 813502012767 (33) 813502012873 (34) 813502012873 ***Removed from scope March 15, 2024*** (4) 00813502011029 (5) 00813502011869 (6) 00813502012811 (11) 4260113630273 (14) 813502011951
Quantity Affected: 91,914 (65,857 US; 26,075 OUS)
Reason for Recall
IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.
Distribution
Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-27
Company
Danvers, MA
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 164 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Abiomed, Inc. has 66 FDA actions in our database, including 61 recalls and 5 clearances.
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 (Abiomed, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abiomed, Inc. have FDA actions?
Abiomed, Inc. has 66 FDA actions in our database, including 61 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0980-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29