Abbott 2025-04-30 Health serious FDA
Health · FDA · Recall #FDA-Z-1643-2025
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080 Recall
Issued April 30, 2025 · Abbott
In April 2025, Abbott recalled the Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.
What you should do
- 1 Stop using Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Abbott 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
- Abbott
- Category
- Health
- Recall date
- April 30, 2025
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution.
- Recall number
- FDA-Z-1643-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Abbott has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.