Reported Oct 22, 2025 · Ongoing
ACCOLADE DR EL (Model L321)
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?
- ACCOLADE DR EL (Model L321)
- Lot codes and dates
- GTIN 00802526558986
- Serial Numbers
3,967 of 3,967 codes
100004100005100033100051100054100058100075100076100092100106100107100109100111100115100116100117100118100119100120100121100125100127100128100130100132100133100134100135100137100141100144100147100149100150100158100159100160100161100162100164100165100168100169100173100175100177100178100179100181100182100184100186100187100188100190100191100193100195100197100199
- Serial Numbers702303. GTIN 00802526558986
- Serial Numbers
705212710438719162721673. GTIN 00802526558993
- Serial Numbers
84 of 84 codes
100003100007100008100010100012100013100014100015100016100017100018100019100020100022100023100025100027100028100032100034100036100037100038100039100040100041100043100045100046100047100048100050100052100053100056100057100059100060100061100062100063100064100065100066100067100068100069100070100071100072100073100074100077100078100079100080100081100082100084100085
- Amount recalled
- 7,488 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.
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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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