Health product recall

Ellipse VR and DR (2020-01-22)

Starting date:
January 22, 2020
Posting date:
February 28, 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-72429



Last updated: 2020-03-06

Affected Products

  1. Ellipse VR
  2. Ellipse DR

Reason

Abbott is informing customers that a small number of Ellipse implantable cardioverter defibrillators (ICDS) may lose wireless radiofrequency (RF) communication.

Affected products

A. Ellipse VR

Lot or serial number

Not applicable.

Model or catalog number
  • CD1277-36
  • CD1377-36C
  • CD1377-36QC
Companies
Manufacturer

St-Jude Medical

Cardiac Rhythm Management Division

15900 Valley View Court

Sylmar

91342

California

UNITED STATES


B. Ellipse DR

Lot or serial number

Not applicable.

Model or catalog number
  • CD2277-36Q
  • CD2377-36QC
Companies
Manufacturer

St-Jude Medical

Cardiac Rhythm Management Division

15900 Valley View Court

Sylmar

91342

California

UNITED STATES