Amplatzer TorqVue LP Catheter (Abbott) – shaft breach (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Brand
Abbott
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Abbott is recalling Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080 due to 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 m. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026