Reported Jan 22, 2025 · Ongoing
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
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?
- ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
- Lot codes and dates
- S702 - UDI-DI
0080252655935800802526576508008025265770000080252657810600802526578106
- Serial Numbers
1,823 of 1,823 codes
100789100793100795100814100815100827100828100829100830100831100833100834100836100837100838100839100840100841100853100856100858100860100868100879100880100882100885100887100888100890100892100894100895100896100897100898100899100900100903100904100905100907100908100909100911100921100922100923100925100926100927100928100929100930100931100932100933100935100936100937
- S722 - UDI-DI
00802526559372008025265765150080252657811300802526593239
- Serial Numbers
620 of 620 codes
100037100038100039100040100041100042100044100046100047100048100049100050100053100054100055100056100057100059100060100061100067100068100070100071100072100073100075100076100077100078100080100081100082100083100084100086100088100089100090100091100092100093100096700001700002700003700004700005700006700007700008700009700011700012700013700014700016700017700018700019
- S702 - 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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