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Accolade™ and visionist™ crt-p pacemakers

Official notice

22 Aug 2025

HighHealth Canada

An official Health Canada notice concerns Accolade™ and visionist™ crt-p pacemakers. 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 Published 2025-08-22.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76710

Official notice

2025-08-22

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

76710

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Affected products

Product 1

Affected products - ACCOLADE™ Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - L301

Product 2

Affected products - ACCOLADE™ Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - L321

Product 3

Affected products - ACCOLADE™ Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - L300

Product 4

Affected products - ACCOLADE™ MRI Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - L310

Product 5

Affected products - ACCOLADE™ MRI Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - L311

Product 6

Affected products - ACCOLADE™ MRI Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - L331

Product 7

Affected products - VISIONIST™ CRT-P, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - U225

Product 8

Affected products - VISIONIST™ CRT-P, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - U226

Product 9

Affected products - VISIONIST™ X4 Crt-P, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - U228

Product 10

Affected products - ESSENTIO Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - L100

Product 11

Affected products - ESSENTIO Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - L101

Product 12

Affected products - ESSENTIO Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - L121

Product 13

Affected products - ESSENTIO MRI Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - L110

Product 14

Affected products - ESSENTIO MRI Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - L111

Product 15

Affected products - ESSENTIO MRI Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - L131

Product 16

Affected products - PROPONENT Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - L200

Product 17

Affected products - PROPONENT Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - L201

Product 18

Affected products - PROPONENT Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - L209

Product 19

Affected products - PROPONENT Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - L221

Product 20

Affected products - PROPONENT MRI Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - L210

Product 21

Affected products - PROPONENT MRI Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - L211

Product 22

Affected products - PROPONENT MRI Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - L231

Product 23

Affected products - ALTRUA 2 Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - S701

Product 24

Affected products - ALTRUA 2 Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - S702

Product 25

Affected products - ALTRUA 2 Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - S722

Product 26

Affected products - VALITUDE CRT-P, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - U125

Product 27

Affected products - VALITUDE X4 Crt-P, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - U128

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Boston Scientific, Accolade™ And Visionist™ Crt-p Pacemakers.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

76710

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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