Health product recall

Zenith Alpha Abdominal Endovascular Graft (2019-04-25)

Starting date:
April 25, 2019
Posting date:
April 30, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69792

Last updated: 2019-04-30

Affected Products

Zenith Alpha Abdominal Endovascular Graft

Reason

Cook (Canada) Inc. has learned from one of their manufacturers, William Cook Europe, that specific lots of the Zenith Alpha Abdominal Endovascular Graft may contain a damaged grey safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard or troubleshooting method provided in the instruction for use (IFU).

Potential adverse events that may occur if an affected product is used include a prolonged procedure and open surgical intervention.

Devices already implanted are not affected by this recall.

Affected products

Zenith Alpha Abdominal Endovascular Graft

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • ZIMB-22-108
  • ZIMB-22-70
  • ZIMB-22-84
  • ZIMB-22-98
  • ZIMB-24-70
  • ZIMB-24-84
  • ZIMB-26-108
  • ZIMB-26-70
  • ZIMB-26-84
  • ZIMB-26-98
  • ZIMB-28-108
  • ZIMB-28-118
  • ZIMB-28-128
  • ZIMB-28-70
  • ZIMB-28-84
  • ZIMB-28-98
  • ZIMB-30-108
  • ZIMB-30-84
  • ZIMB-30-98
  • ZIMB-32-108
  • ZIMB-32-84
  • ZIMB-32-98
  • ZIMB-36-70
Companies
Manufacturer
William Cook Europe APS
Sandet 6
Bjaeverskov
4632
DENMARK