Ingenio Family DREL Pacemakers and CRT- Ps (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:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-75923
Last updated:
2021-06-30
Affected Products
A. Advantio Pacemaker
B. Ingenio Pacemaker
C. Invive Cardiac Resynchronization Therapy Pacemaker
D. Vitalio Pacemaker
E. Inliven Cardiac Resynchronization therapy Pacemaker
Reason
L’impédance de la batterie EL augmente avec le temps, en fonction de la durée de l’implant et de la consommation d’énergie. Cette augmentation de l’impédance de la batterie peut entraîner des baisses de tension transitoires du dispositif pendant les périodes de forte consommation d’énergie associées à la communication télémétrique au moyen d’un programmateur ou d’un communicateur LATITUDE. L’appareil doit être remplacé.
Affected products
A. Advantio Pacemaker
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
K084
Companies
- Manufacturer
-
Boston Scientific Corporation
4100 Hamline Avenue North
St. Paul
55112-5798
Minnesota
UNITED STATES
B. Ingenio Pacemaker
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
K184
Companies
- Manufacturer
-
Boston Scientific Corporation
4100 Hamline Avenue North
St. Paul
55112-5798
Minnesota
UNITED STATES
C. Invive Cardiac Resynchronization Therapy Pacemaker
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
V182
V183
Companies
- Manufacturer
-
Boston Scientific Corporation
4100 Hamline Avenue North
St. Paul
55112-5798
Minnesota
UNITED STATES
D. Vitalio Pacemaker
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
K284
Companies
- Manufacturer
-
Boston Scientific Corporation
4100 Hamline Avenue North
St. Paul
55112-5798
Minnesota
UNITED STATES
E. Inliven Cardiac Resynchronization therapy Pacemaker
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
V284
V285
Companies
- Manufacturer
-
Boston Scientific Corporation
4100 Hamline Avenue North
St. Paul
55112-5798
Minnesota
UNITED STATES