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
- Reliant Stent Graft Balloon Catheter
- Endurant II Stent Graft System
- 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