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
- ACCOLADE PACEMAKER
- ACCOLADE MRI PACEMAKER
- VISIONIST CRT-P
- 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