Accolade Family Pacemakers (2021-06-03)
- Starting date:
- June 3, 2021
- Posting date:
- June 30, 2021
- 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-75921
Last updated:
2021-06-30
Affected Products
A. Accolade Pacemaker
B. Accolade MRI Pacemaker
C. VisionST CRT-P
D. VisionST X4 CRT-P
Reason
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.
Affected products
A. Accolade Pacemaker
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
L300
L301
L321
Companies
- Manufacturer
-
Boston Scientific Corporation
4100 Hamline Avenue North
St. Paul
55112-5798
Minnesota
UNITED STATES
B. Accolade MRI Pacemaker
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
L310
L311
L331
Companies
- Manufacturer
-
Boston Scientific Corporation
4100 Hamline Avenue North
St. Paul
55112-5798
Minnesota
UNITED STATES
C. VisionST CRT-P
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
U225
U226
Companies
- Manufacturer
-
Boston Scientific Corporation
4100 Hamline Avenue North
St. Paul
55112-5798
Minnesota
UNITED STATES
D. VisionST X4 CRT-P
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
U228
Companies
- Manufacturer
-
Boston Scientific Corporation
4100 Hamline Avenue North
St. Paul
55112-5798
Minnesota
UNITED STATES