Reported Oct 22, 2025 · Ongoing
Model Number U226, VISIONIST CRT-P EL
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?
- Model Number U226, VISIONIST CRT-P EL
- Lot codes and dates
- GTIN 00802526559457
- Serial numbers
235 of 235 codes
700333700335700342700344700346700347700352700364700372700386700388700390700391700425700426700427700428700429700437700448700455700460700461700464700490700498700500700520700538700539700570700587700591700638700653700665700676700693700700700702700704700705700707700708700711700718700720700722700735700736700755700759700765700768700774700782700790700794700796700809
- Serial numbers
722 of 722 codes
100006100009100011100012100013100014100016100017100018100019100021100022100023100024100025100026100027100028100029100030100032100034100035100038100039100042100044100045100046100048100049100050100052100053100054100055100058100059100061100062100063100066100067100068100069100070100073100075100076100077100081100087100089100092100094100095100096100098100100100101
- Serial numbers
93 of 93 codes
100074100085100106700079700109700110700123700219700222700232700266700278700279700282700290700300700302700305700310700323700325700366700458700503700543700608700651700662700688700692700694700764700798700805700810700833700837700839700840700848700852700854700856700857700863700867700896700898700934700955700995701095701103701205701208701209701282701285701289701293
- Amount recalled
- 1,050 units
This recall covers 34 products
The agency filed one notice per product. You are reading one of them; the other 33 are below.
21 more are in the archive.
Why it was recalled
Stop using this product now
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
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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