VISIONIST CRT-P, X4 CRT-P and Autogen CRT-D (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-65800
Affected products
- AUTOGEN CRT-D
- VISIONIST CRT-P
- VISIONIST X4 CRT-P
Reason
Important programming information to prevent an unintended asynchronous biventricular (BiV) pacing behavior when tracking elevated Atrial Intrinsic rhythms in certain Boston Scientific Cardiac Resynchronization Therapy (CRT) pacemakers (CRT-Ps) and defibrillators (CRT-Ds). Repeated detection of this unintended asynchronous BIV pacing behavior may result in the implanted device reverting to a permanent safety mode (safety coreT) status thus requiring early replacement.
Affected products
A. AUTOGEN CRT-D
Lot or serial number
Not applicable
Model or catalog number
- G172
- G173
- G175
- G179
Companies
- Manufacturer
-
Cardiac Pacemakers Incorporated
4100 Hamline Avenue North
St. Paul
55112
Minnesota
UNITED STATES
B. 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
C. 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