Summary
The FDA issued a Class II for GORE CARDIOFORM ASD Occluder. cardiovascular implant. by W L Gore & Associates, Inc.. Reason: Due to manufacturing records (Release Test Results) indicating "Failed"..
Details
Source
Device Recall
External ID
Z-0136-2023
Action Date
2022-11-02
Status
Ongoing
Category
device
Product Description
GORE CARDIOFORM ASD Occluder. cardiovascular implant.
Lot/Code Info: Model Numbers: ASD37A UDI-DI Codes: 00733132636501 Serial Numbers: 24468090 24468092 24468093 24468096 24468097 24468098 24468099 24468103 24468104 24480314 24480315 24480316 24480318 24468102 24468094 24468100 24468101 24480317 24468091 24468095 Model Number: ASD44A UDI-DI Code: 00733132636518 Serial Numbers: 24281498 24281499 24281500 24281501 24281502 24281507 24281509 24281511 24281512 24429270 24429271 24429276 24429278 24429279 24480351 24480352 24480353 24545359 24550148 24550149 24578446 24578447 24281506 24429272 24429273 24429274 24429277 24545360 24545362 24550147 24550150 24550151 24578443 24578445 24281503 24281504 24281505 24281508 24281510 24429275 24480354 24480355 24545358 Model Number: ASD44E UDI-DI Code: 00733132636617 Serial Numbers: 24305083 24305081 24550693 24550694 24305079 24305080 24305082 24550695 24550696 24550697
Quantity Affected: 98 units
Reason for Recall
Due to manufacturing records (Release Test Results) indicating "Failed".
Distribution
Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA, IA, ID, IL, ME, MN, NC, NY, JPA, TN, TX, WA, and WI. The countries of Denmark, and Japan.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-21
Company
Flagstaff, 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 128 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-0136-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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