Edwards Lifesciences, LLC 2023-11-15 Health serious FDA
Health · FDA · Recall #FDA-Z-0238-2024
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 Recall
Issued November 15, 2023 · Edwards Lifesciences, LLC
In November 2023, Edwards Lifesciences, LLC recalled the Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
What you should do
- 1 Stop using Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Edwards Lifesciences, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Edwards Lifesciences, LLC
- Category
- Health
- Recall date
- November 15, 2023
- Units affected
- Not reported
- Sold at
- OUS: Singapore, Taiwan, Canada
- Recall number
- FDA-Z-0238-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Edwards Lifesciences, LLC has 2 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.