Health product recall

Medtronic Stent Graft Systems (2019-02-10)

Starting date:
February 10, 2019
Posting date:
February 22, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69120

Affected Products

  1. Reliant Stent Graft Balloon Catheter
  2. Endurant II Stent Graft System
  3. Talent Endoluminal Occluder System

Reason

This voluntary recall is being conducted due to the potential that the sterile barrier of the products may have been compromised during conversion to demo product use and demo product labeling.
This issue does not affect any other Medtronic shipments, products or implantable devices.

Affected products

A. Reliant Stent Graft Balloon Catheter

Lot or serial number
  • 9420967
Model or catalog number
  • AB46
Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway
Minneapolis, Minnesota
55432
UNITED STATES

B. Endurant II Stent Graft System

Lot or serial number
  • V07341500
  • V07388523
Model or catalog number
  • ETLW1616C124EE
  • ETUF3614C102EE
Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway
Minneapolis, Minnesota
55432
UNITED STATES

C. Talent Endoluminal Occluder System

Lot or serial number
  • V08141796
Model or catalog number
  • OCL24
Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway
Minneapolis, Minnesota
55432
UNITED STATES