Amplatzer TorqVue LP Delivery System (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 Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
Brand
Abbott
Lot Codes / Batch Numbers
Models: 1. 9-TVLP4F90/060, UDI-DI 00811806011578 Lots 9206150 10040010 10068340 10227816 10341801
Products Sold
Models: 1. 9-TVLP4F90/060; UDI-DI 00811806011561 Lots 9114256 9125090 9157327 9211450 10005333 10080103 10092488 10092519 10212158 10248201 10265245 10333989 10334851 10353324 2. 9-TVLP4F90/080; UDI-DI 00811806011578 Lots 9206150 10040010 10068340 10227816 10341801
Abbott is recalling Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080 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