The Recall Desk
HighFDA (Devices)·Z-0464-2022·Announced 2022-01-12

Medtronic Abre Venous Stent System recalled for reports of stent migration

Medtronic is recalling the Abre Venous Self-Expanding Stent System due to reports of stent migration. Approximately 21,653 devices were distributed nationwide and internationally.

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 a Class II medical device recall for confirmed reports of stent migration, a mechanical failure in a critical vascular device. Although no illnesses or injuries have been reported in the source text, stent migration constitutes a significant risk of harm that may necessitate medical intervention, meeting the rubric criterion for High severity.

Plain-English summary

Medtronic Inc. is recalling the Instructions for Use for all model numbers of the Abre Venous Self-Expanding Stent System. The recall was initiated due to reports that the stent may migrate from its intended placement location.

Stent migration can compromise proper venous function and may require additional medical intervention. This is a Class II recall.

The recall affects approximately 21,653 devices distributed nationwide and to U.S. military and government facilities. International distribution included more than 40 countries across North America, Europe, Asia, Africa, Australia, and South America.

Patients who have received this stent should contact their healthcare provider or Medtronic for guidance regarding whether they have been affected and what monitoring or follow-up may be appropriate.

The recalled product

Product
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Cardiovascular / Venous Stent
Hazard
  • stent-migration
  • device-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • The IFU for all model numbers and serial numbers.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category