Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compat
Summary
The FDA issued a Class II for Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXX by W. L. Gore & Associates Inc.. Reason: Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inf.
Details
Source
Device Recall
External ID
Z-2340-2021
Action Date
2021-09-01
Status
Ongoing
Category
device
Product Description
Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489
Lot/Code Info: Serial Numbers between 22982051 - 23516741
Quantity Affected: 3,364 units
Reason for Recall
Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to inflate.
Distribution
Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of AUS, CAN, CHE, DEU, DNK, ESP, FIN, FRA, GBR, GRC, HRV, HUN, IRL, ISR, ITA, JPN, MEX, NLD, NOR, POL, PRT, SMR, SWE.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-12
Company
Phoenix, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
W. L. Gore & Associates Inc. has 25 FDA actions in our database, including 20 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (W. L. Gore & Associates Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does W. L. Gore & Associates Inc. have FDA actions?
W. L. Gore & Associates Inc. has 25 FDA actions in our database, including 20 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2340-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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