Reported Jan 22, 2025 · Ongoing
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
Boston Scientific Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 4100 Hamline Ave N · Saint Paul, MN · 55112-5700
Is this the product you have?
- VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
- Lot codes and dates
- U125 - UDI-DI
0080252655938900802526559396008025265771090080252657879300802526577024
- Serial Numbers
1,774 of 1,774 codes
100319100323100329100331100333100379100380100384100385100386100390100392100439100448100452100453100462100466100467100480100481100482100485100486100495100496100497100498100499100500100502100505100506100510100514100515100517100518100524100526100539100540100541100546100548100549100552100585100650100653100656100657100658100690100692100693100697100699100700100701
- U128 - UDI-DI
008025265594020080252655941900802526576522008025265781200080252657703100802526593284
- Serial Numbers
2,849 of 2,849 codes
100719100721100724100725100726100727100730100731100732100735100736100737100740100742100744100748100749100750100753100757100759100761100763100765100768100769100772100773100774100777100784100785100787100791100793100794100798100801100805100807100808100811100816100820100821100822100825100829100831100833100834100835100839100841100842100849100850100852100853100854
- U125 - UDI-DI
- Amount recalled
- 156,329 units (59,937 US, 96,792 OUS) in total
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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