Health product recall

ACCOLADE Pacemaker, MRI Pacemaker, VISIONIST CRT-P and X4 CRT-P (2017-12-19)

Starting date:
December 19, 2017
Posting date:
January 29, 2018
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-65790

Affected products

  1. ACCOLADE PACEMAKER
  2. ACCOLADE MRI PACEMAKER
  3. VISIONIST CRT-P
  4. VISIONIST X4 CRT-P

Reason

Intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition.

Affected products

A. ACCOLADE PACEMAKER

Lot or serial number

Not applicable

Model or catalog number
  • L300
  • L301
  • L321
Companies
Manufacturer
Cardiac Pacemakers Incorporated
4100 Hamline Avenue North
St. Paul
55112
Minnesota
UNITED STATES

B. ACCOLADE MRI PACEMAKER

Lot or serial number

Not applicable

Model or catalog number
  • L310
  • L311
  • L331
Companies
Manufacturer
Cardiac Pacemakers Incorporated
4100 Hamline Avenue North
St. Paul
55112
Minnesota
UNITED STATES

C. VISIONIST CRT-P

Lot or serial number

Not applicable

Model or catalog number

U225

Companies
Manufacturer
Cardiac Pacemakers Incorporated
4100 Hamline Avenue North
St. Paul
55112
Minnesota
UNITED STATES

D. VISIONIST X4 CRT-P

Lot or serial number

Not applicable

Model or catalog number

U228

Companies
Manufacturer
Cardiac Pacemakers Incorporated
4100 Hamline Avenue North
St. Paul
55112
Minnesota
UNITED STATES