ACCOLADE™ and VISIONIST™ CRT-P Pacemakers
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
ACCOLADE™ Pacemaker |
More than 10 numbers, contact manufacturer. |
L301 |
ACCOLADE™ Pacemaker |
More than 10 numbers, contact manufacturer. |
L321 |
ACCOLADE™ Pacemaker |
More than 10 numbers, contact manufacturer. |
L300 |
ACCOLADE™ MRI Pacemaker |
More than 10 numbers, contact manufacturer. |
L310 |
ACCOLADE™ MRI Pacemaker |
More than 10 numbers, contact manufacturer. |
L311 |
ACCOLADE™ MRI Pacemaker |
More than 10 numbers, contact manufacturer. |
L331 |
VISIONIST™ CRT-P |
More than 10 numbers, contact manufacturer. |
U225 |
VISIONIST™ CRT-P |
More than 10 numbers, contact manufacturer. |
U226 |
VISIONIST™ X4 Crt-P |
More than 10 numbers, contact manufacturer. |
U228 |
ESSENTIO Pacemaker |
More than 10 numbers, contact manufacturer. |
L100 |
ESSENTIO Pacemaker |
More than 10 numbers, contact manufacturer. |
L101 |
ESSENTIO Pacemaker |
More than 10 numbers, contact manufacturer. |
L121 |
ESSENTIO MRI Pacemaker |
More than 10 numbers, contact manufacturer. |
L110 |
ESSENTIO MRI Pacemaker |
More than 10 numbers, contact manufacturer. |
L111 |
ESSENTIO MRI Pacemaker |
More than 10 numbers, contact manufacturer. |
L131 |
PROPONENT Pacemaker |
More than 10 numbers, contact manufacturer. |
L200 |
PROPONENT Pacemaker |
More than 10 numbers, contact manufacturer. |
L201 |
PROPONENT Pacemaker |
More than 10 numbers, contact manufacturer. |
L209 |
PROPONENT Pacemaker |
More than 10 numbers, contact manufacturer. |
L221 |
PROPONENT MRI Pacemaker |
More than 10 numbers, contact manufacturer. |
L210 |
PROPONENT MRI Pacemaker |
More than 10 numbers, contact manufacturer. |
L211 |
PROPONENT MRI Pacemaker |
More than 10 numbers, contact manufacturer. |
L231 |
ALTRUA 2 Pacemaker |
More than 10 numbers, contact manufacturer. |
S701 |
ALTRUA 2 Pacemaker |
More than 10 numbers, contact manufacturer. |
S702 |
ALTRUA 2 Pacemaker |
More than 10 numbers, contact manufacturer. |
S722 |
VALITUDE CRT-P |
More than 10 numbers, contact manufacturer. |
U125 |
VALITUDE X4 Crt-P |
More than 10 numbers, contact manufacturer. |
U128 |
Issue
Boston Scientific is initiating an advisory to provide information about a subset of pacemakers from the ACCOLADE™ family and VISIONIST™ CRT-Ps with an increased potential to initiate safety mode during telemetry or, in rare instances, other normal, higher-power operations due to latent, high battery impedance when the device reaches approximately four (4) years or less of remaining battery longevity.
Recall start date: December 12, 2024
Additional information
Details
Boston Scientific Corporation
4100 Hamline Avenue North, St. Paul, Minnesota, United States, 55112-5798
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