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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Surgical Equipment

Abbott Amplatzer TorqVue Delivery Systems Recalled for Air Embolism Risk

Agency Publication Date: April 21, 2025
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Summary

Abbott is recalling 7,533 Amplatzer TorqVue LP Delivery Systems and Catheters because the devices may have a small, invisible breach in the shaft. This defect can lead to unexpected blood loss or allow air to enter the patient's bloodstream (air embolism) during medical procedures. No incidents or injuries have been reported to date, but the manufacturer initiated this voluntary recall to prevent potential complications.

Risk

A breach in the shaft of these delivery systems can cause serious medical issues, including an air embolism, which occurs when air bubbles enter a blood vessel and block blood flow. Because the breach is not visibly detectable, it may also lead to prolonged procedures and significant blood loss.

What You Should Do

  1. This recall affects Amplatzer TorqVue LP Delivery Systems (models 9-TVLP4F90/060 and 9-TVLP4F90/080) and Amplatzer TorqVue LP Catheters (model 9-TVLPC4F90/080).
  2. Check the model number, UDI-DI, and lot number on your product packaging to identify if your specific device is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately and sequester any remaining inventory to ensure it is not used in clinical procedures.
  4. Contact Abbott or your medical distributor to arrange for the return, replacement, or correction of any affected units.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Amplatzer TorqVue LP Delivery System (4F/90/060)
Model / REF:
9-TVLP4F90/060
Lot Numbers:
9114256
9125090
9157327
9211450
10005333
10080103
10092488
10092519
10212158
10248201
10265245
10333989
10334851
10353324
UDI:
00811806011561

Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress.

Product: Amplatzer TorqVue LP Delivery System (4F/90/080)
Model / REF:
9-TVLP4F90/080
Lot Numbers:
9206150
10040010
10068340
10227816
10341801
UDI:
00811806011578

Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress.

Product: Amplatzer TorqVue LP Catheter (TVLPC)
Model / REF:
9-TVLPC4F90/080
Lot Numbers:
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
UDI:
00811806012926

Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96545
Status: Active
Manufacturer: Abbott
Sold By: Hospitals; Surgical Centers; Medical Distributors
Manufactured In: United States
Units Affected: 2 products (4,850; 2683)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.