Health product recall

Zenith Alpha Abdominal Endovascular Graft (2020-06-02)

Starting date:
June 2, 2020
Posting date:
June 19, 2020
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-73357

Last updated: 2020-06-19

Affected Products

Zenith Alpha Abdominal Endovascular Graft

Reason

The affected lots may contain a damaged bushing within the delivery system, which could potentially result in difficulty or an inability to fully deploy the graft via the standard method provided in the instructions for use.

Affected products

Zenith Alpha Abdominal Endovascular Graft

Lot or serial number
  • More than 10 numbers, contact manufacturer.
Model or catalog number
  • ZIMB-22-84
  • ZIMB-24-70
  • ZIMB-24-84
  • ZIMB-24-98
  • ZIMB-26-84
  • ZIMB-26-98
  • ZIMB-28-108
  • ZIMB-28-128
  • ZIMB-28-84
  • ZIMB-28-98
  • ZIMB-30-84
  • ZIMB-30-98
  • ZIMB-32-98
Companies
Manufacturer

Cook Inc.

750 Daniels Way

Bloomington

47404

Indiana

UNITED STATES