Reported Jan 22, 2025 · Ongoing
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), 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?
ESSENTIO DR PacemakerSL (Model Number L101SL MRI (Model Number L111)EL (Model Number L121)and EL MRI (Model Number L131)
- Lot codes and dates
- L101 - UDI-DI
00802526558924 and 008025265589310080252657631700802526576812
- Serial Numbers7
4,643 of 4,643 codes
100683100690100697100701100702100703100705100706100723100724100726100727100735100740100741100762100792101029101217101364101367101370101385101392101404101408101425101428101441101480101498101499101512101558101566101570101578101595101624101673101680101694101716101721101724101731101732101742101747101757101774101775101777101784101793101799101801101810101813101830
- L101 - 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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