Abbott recalls specific models of Amplatzer TorqVue LP Delivery System (TVLP) due to potential small breaches causing blood loss or air embolism during procedures. Affected units include model numbers 9-TVLP4F90/060 and 9-TVLP4F90/080 with listed lot numbers.
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.
Abbott is recalling two specific models of Amplatzer TorqVue LP Delivery System (TVLP) because they may have a small, invisible breach that could cause blood loss or air embolism during medical procedures. This recall affects patients undergoing certain surgeries where the device is used.
The device may have a small, invisible breach in the shaft that can lead to prolonged procedures, blood loss, or air entering the bloodstream, potentially causing air embolism. This breach is not visible during normal use and can occur under the strain relief of the delivery system.
Patients who have received the recalled Amplatzer TorqVue LP Delivery System models during medical procedures are most at risk. Healthcare providers using these specific models for procedures should also be aware.
Check for model numbers 9-TVLP4F90/060 or 9-TVLP4F90/080 on the device. Affected units also have specific lot numbers listed in the recall notice.
Look for model numbers 9-TVLP4F90/060 or 9-TVLP4F90/080 on the device to confirm if it is affected.
The device may have a small, invisible breach in the shaft that can cause blood loss or air embolism during medical procedures.
Check for model numbers 9-TVLP4F90/060 or 9-TVLP4F90/080 on the device, as these specific models are affected.
The recall does not specify a remedy, so contact Abbott directly for guidance on next steps.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1643-2025 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1643-2025 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
