Reported Jan 22, 2025 · Ongoing
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (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?
ACCOLADE DR PacemakerSL (Model Number L301)SL MRI (Model Number L311)EL (Model Number L321)and EL MRI (Model Number L331)
- Lot codes and dates
- L301 - UDI-DI
0080252655917400802526559181
- Serial Numbers7
4,648 of 4,648 codes
100752100892100893100931100932100938100941100980100981100982100985100986100988100989100990100991100997101000101002101004101006101014101016101017101020101021101022101024101025101033101036101037101042101043101044101046101048101050101053101059101061101067101214101218101221101223101224101225101382101388101393101400101406101409101411101412101418101423101424101427
- L301 - 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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