Health product recall

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

  1. AUTOGEN CRT-D
  2. VISIONIST CRT-P
  3. 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