Reported Jan 22, 2025 · Ongoing
VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
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?
- VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
- Lot codes and dates
- U225 - UDI-DI
00802526559433008025265771160080252657704800802526578809
- Serial Numbers
2,107 of 2,107 codes
100320100321100388100543100545100712100717100720100734100747100787100800100804100806100807100810100819100827100828100832100834100835100845100849100850100851100852100853100856100858100865100874100879100880100887100888100889100890100892100894100895100900100901100902100905100906100907100908100913100915100916100917100919100921100922100923100924100926100928100929
- U226 - UDI-DI
00802526559457008025265594640080252657706200802526577123
- Serial Numbers
242 of 242 codes
700333700460700461700484700490700498700587700591100052100053100054100055100058100059100060100061100062100063100066100067100068100069100070100107100108100109100111100112100113100116100117100118100120100123100124100126100127100128100129100132100133100134100135100136700002700003700004700006700007700008700009700010700011700012700013700014700015700018700019700020
- U228 - UDI-DI
008025265771300080252655948800802526578830
- Serial Numbers
2,269 of 2,269 codes
702970709765100745100815100824100836100851100868100877100890100891100892100894100901100902100904100919100920100923100926100928100942100944100950100951100963100976100986101029101030101031101033101034101036101068101071101085101105101150101151101152101153101155101156101191101192101197101198101209101215101216101217101218101252101262101270101286101287101288101339
- U225 - 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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