The Recall Desk
HighFDA (Devices)·Z-1644-2025·Announced 2025-04-30

Amplatzer Catheter Recalled Due to Hidden Shaft Defect

Abbott's Amplatzer TorqVue LP Catheter is recalled due to a hidden shaft breach that could cause blood loss, prolonged procedures, or air embolism. Approximately 2,683 units with specific lot numbers are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a medical device with a non-visible manufacturing defect that poses risk of serious complications including air embolism. No injuries or hospitalizations have been reported, meeting the criteria for High severity as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Abbott's Amplatzer TorqVue LP Catheter, Model no. 9-TVLPC4F90/080, is being recalled. The device was distributed worldwide, including throughout the United States. Approximately 2,683 units with specific lot numbers have been identified as affected.

The catheter may contain a small breach in the proximal end of the shaft under the strain relief of the delivery system. This breach is not visibly detectable through standard inspection. If present, the breach could lead to a prolonged procedure, blood loss, or air ingress with the potential for air embolism.

Healthcare facilities should verify their inventory against the affected lot numbers provided. Further guidance on management of affected units should be obtained from the FDA or Abbott.

The recalled product

Product
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Manufacturer
Abbott
Category
Medical Device — Catheter
Hazard
  • air-embolism
  • blood-loss
  • device-defect

Distribution

Distributed nationwide across the United States.

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