Abbott recalls Amplatzer TorqVue LP Catheter model 9-TVLPC4F90/080 due to potential small breach in the shaft that could cause blood loss or air embolism during procedures.
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 a specific model of Amplatzer TorqVue LP Catheter because it may have a small, invisible breach in the catheter shaft. This breach could lead to prolonged procedures, blood loss, or air embolism if the catheter is used.
The catheter may have a small, invisible breach near the shaft's end that isn't detectable during normal use. This breach could cause blood loss or air entering the bloodstream, leading to air embolism during medical procedures.
Healthcare professionals using the Amplatzer TorqVue LP Catheter model 9-TVLPC4F90/080 for procedures are most at risk. Patients receiving the catheter during procedures may also be affected.
Check for the model number 9-TVLPC4F90/080 on the catheter's packaging or label. The catheter was sold with specific lot numbers listed in the recall notice.
Look for the model number 9-TVLPC4F90/080 on the catheter's packaging or label.
The recall states the catheter may have a small, invisible breach that could lead to blood loss or air embolism, so it is not safe to use without checking the recall.
The recall does not specify a remedy, so contact Abbott directly for guidance on whether to stop using it.
Check the model number on the catheter's packaging or label; the recalled model is 9-TVLPC4F90/080 with specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1644-2025 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1644-2025 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.