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Crome and cobalt mri surescan
Official notice
4 Jul 2022
Last checked
4 Jul 2022
An official Health Canada notice concerns Crome and cobalt mri surescan. Medtronic is notifying health care professionals of the potential for reduced shock energy (~79% of programmed energy) during high-voltage (hv) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (crt-ds). Through 03-June-2022, Medtronic has identified 27 devices (0.03% of devices distributed worldwide) that have experienced a reduced-energy shock, which is accompanied by a short circuit protection (scp) alert. Medtronic has not received any reports of permanent harm or death due to this issue. Medtronic is also requesting hospitals quarantine and return a subset of non-implanted Medtronic Cobalt and Crome icds crt-ds. An identified list (i.e. Subset) of specific serial numbers may have a manufacturing non-conformance that can contribute to the potential for reduced shock energy during high-voltage therapy. These devices will undergo additional inspection to ensure conformance to manufacturing specifications, once retrieved from the field. Recall start date: June 22, 2022 Published 2022-07-04.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64330
Official notice
2022-07-04
The hazard
The hazard
Medtronic is notifying health care professionals of the potential for reduced shock energy (~79% of programmed energy) during high-voltage (hv) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (crt-ds). Through 03-June-2022, Medtronic has identified 27 devices (0.03% of devices distributed worldwide) that have experienced a reduced-energy shock, which is accompanied by a short circuit protection (scp) alert. Medtronic has not received any reports of permanent harm or death due to this issue. Medtronic is also requesting hospitals quarantine and return a subset of non-implanted Medtronic Cobalt and Crome icds crt-ds. An identified list (i.e. Subset) of specific serial numbers may have a manufacturing non-conformance that can contribute to the potential for reduced shock energy during high-voltage therapy. These devices will undergo additional inspection to ensure conformance to manufacturing specifications, once retrieved from the field. Recall start date: June 22, 2022
How to check if you're affected
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.
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
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Company & contacts
Company & contacts
Brand: Medtronic, Crome And Cobalt Mri Surescan.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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