Use cautionMedical device recall · FDA · Published March 17, 2025
Abbott Amplatzer TorqVue LP Delivery System Recall: Risk of Blood Loss or Air Embolism
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.
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📍Recalling firmAbbott5050 Nathan Ln N · Plymouth, MN 55442-3209
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/52627-abbott-amplatzer-torqvue-lp-delivery-system-recall-risk-of-blood.
“Abbott Amplatzer TorqVue LP Delivery System Recall: Risk of Blood Loss or Air Embolism.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52627-abbott-amplatzer-torqvue-lp-delivery-system-recall-risk-of-blood. Based on FDA recall #Z-1643-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1643-2025%22&limit=1).
The FDA announced on March 17, 2025, that Abbott is recalling Amplatzer TorqVue LP Delivery Systems due to a potential breach in the shaft. The defect may lead to prolonged procedures, blood loss, or air embolism. Owners should contact Abbott for further instructions.
How to tell if you have it
Brand: Abbott
Product: Amplatzer TorqVue LP Delivery System (TVLP)
Model nos.: 9-TVLP4F90/060 and 9-TVLP4F90/080
Lots for Model 9-TVLP4F90/060: 9114256, 9125090, 9157327, 9211450, 10005333, 10080103, 10092488, 10092519, 10212158, 10248201, 10265245, 10333989, 10334851, 10353324
Lots for Model 9-TVLP4F90/080: 9206150, 10040010, 10068340, 10227816, 10341801
Distribution: US Nationwide
The hazard
The device may have a small breach in the proximal end of the shaft under the strain relief that is not visibly detectable. This breach may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.
Context
GovInfoNow's records show Abbott has 12 other recalls on record since April 5, 2018. Other recent recalls of similar products include the Abbott TactiFlex Sensor Catheter Recall (Sept. 10, 2025), the Abbott NT2000iX RF Generator Recall (Sept. 28, 2023), and the Abbott Amplatzer Steerable Delivery Sheath Recall (June 12, 2023). Other recent recalls of similar products include the Boston Scientific FARADRIVE Steerable Sheath Recall (June 11, 2026) and the Boston Scientific FARADRIVE Steerable Sheath Clear IDE Recall (June 11, 2026).
How to tell if you have this one
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.
Brand
Abbott
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
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.
Official source: FDA Recall #Z-1643-2025 (March 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1643-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.