Recall Z-1644-2025 ยท DQY Catheter, Percutaneous
Abbott
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
| Date | Apr 21, 2025 (initiated Mar 17, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | On March 17, 2025, the firm notified customers via hand-delivered customer communications titled "Urgent Medical Device Recall." Customers were instructed to share the notice with applicable personnel and to return any remaining unused devices from impacted lots. Abbott representatives will assist with product return and replenishment. If you have any questions, please contact your local Sales Representative or Abbott Support at 1-800-544-1664. |
| Quantity | 2683 |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162228 | TorqVue Low Profile Delivery Catheter Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor, Sep 9, 2016 |