CLASS II ONGOING Device recall · Reported 30 Apr 2025 · FDA Enforcement Report
Amplatzer TorqVue LP Catheter (Tvlpc) recalled by Abbott
Abbott is recalling Amplatzer TorqVue LP Catheter (Tvlpc), distributed nationwide in the US. The recall was initiated on 17 Mar 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1644-2025
- FDA event ID
- 96545
- Recalling firm
- Abbott, Plymouth, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Mar 2025
- FDA classified
- 21 Apr 2025
- Reported
- 30 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 17 Mar 2025 | Recall initiated by company | |
| 21 Apr 2025 | Classified by FDA | +35 days |
| 30 Apr 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI 00811806012926 Lots 9078966 9093895 9134623 9144113 9148110 9148579 9155868 9158302 9241591 9241593 10004059 10011461 10011462 10011463 10011465 10017790 10017792 10196106 10196119 10198795 10198801 10198889 10207472 10207503 10274454 10283818
Where was it sold?
Worldwide - US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96545This product is part of a recall event; the main page for the event is Amplatzer TorqVue LP Delivery System (TVLP) recalled by Abbott.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Amplatzer TorqVue LP Delivery System (TVLP) recalled by Abbott | Abbott | Other | Nationwide |
More recalls from Abbott
All 20Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |