Reported Jan 22, 2025 · Ongoing
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model…
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?
PROPONENT DR PacemakerSL (Model Number L201)(VDD) SL (Model Number L209)SL MRI (Model Number L211)EL (Model Number L221)and EL MRI (Model Number L231)
- Lot codes and dates
- L201 - UDI-DI
00802526559044008025265780140080252657637900802526576874
- Serial Number
890 of 890 codes
760500100707100788100793100800100803100804100808100838100839713123714640714796715611715757715779715795715799715802715805715831715842715847715854715886715905715907715912715934715949715953715981715986715991715993716002716005716007716011716016716028716044716045716054716063716066716081716097716106716147716148716162716163716171716182716183716190716194716205716208
- L209 - UDI-DI
0080252655906800802526576386
- Serial Numbers
555 of 555 codes
100161700001700002700003700004700005700006700007700008700009700010700011700012700013700014700015700016700017700018700019700020700021700022700023700024700025700026700027700028700029700030700031700032700033700034700035700037700038700039700040700041700042700043700044700046700047700048700050700051700053700054700055700056700057700058700059700060700061700062700063
- L211 - UDI-DI
00802526578038008025265591050080252657640900802526576904
- Serial Numbers
3,176 of 3,176 codes
251896100885101747101748101796101797101800101813101815101817101819101826101831101832101834101836101837101845101849101852101854101855101857101858101861101870101871101872101873101886101892101905101906101909101914101915101916101921101930101941101958101962101974101991101998102020102028102029102030102033102036102038102041102054102055102056102063102069102099102100
- L201 - 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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