The Recall Desk
HighFDA (Devices)·Z-0623-2024·Announced 2024-01-10

Medtronic Protege GPS Stent System Recalled for Packaging Seal Defects

Medtronic is recalling Protege GPS Self-Expanding Peripheral Stent Systems due to seal defects in product packaging that could compromise sterility. Affected lot B644679 had national distribution.

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: FDA Class II recall with no reported illnesses or injuries. The hazard—potential sterility compromise of an implantable medical device—represents a risk-of-harm product where injury has not yet been reported, meeting the High (3) criteria per the rubric.

Plain-English summary

Medtronic Inc. is recalling the Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, due to seal defects identified in the product packaging. Seal defects could compromise the ability of the packaging to maintain sterility.

The affected product is lot number B644679, identified by UDI-DI 00643169728974. The product had US nationwide distribution in Minnesota. This is a Class II recall issued by the U.S. Food and Drug Administration, with recall number Z-0623-2024.

Patients with implanted stents from the affected lot may contact their healthcare provider for additional guidance regarding this recall.

The recalled product

Product
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Manufacturer
Medtronic Inc.
Category
Medical Device — Vascular Stent System
Hazard
  • seal-defect
  • sterility-compromise

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 (2)

  • Lot number B644679
  • UDI-DI 00643169728974.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category