Reported Jul 14, 2021 · Ongoing
Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 Bldg 3 · Saint Paul, MN · 55112-5700
Is this the product you have?
- Proponent pacemaker
- Modelsa) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
- Lot codes and dates
- a) L200
- Serial Numbers
408 of 408 codes
464370464446464458464460464462464468464470464475464481464482464483464490464498464500464508464512464516464519464526464528464532464563464590705134705580705587705711705751706215708261708589708797708798708802708815708819708820708832708841708843708844708848708851708858708859708874708877708883708886708892708896708907708910708913708914708917708923708928708932708933
- Serial Numbers
395 of 395 codes
100197100197716267716291716760716845716997718600718990742235742270742333742343742359742372742390742461742514742556742588742625742754743187743229743329743535744054746443746451751482100140100164100165100174100181100186100221100243100282100287100290100401100407100410100707100750100827100838100839716162716208716288716289716290716309716419716421716423716424716426
- Serial Numbers
442 of 442 codes
701098701123701125701142100002100006100007100008100009100010100011100012100013100014100015100017100019100020100021100022100023100025100026100027100028100029100030100031100032100034100035100036100037100038100039100040100041100042100043100044100045100046100047100048100049100050100051100052100053100055100056100057100058100059100060100061100062100063100064100065
- Serial Numbers
2,818 of 2,818 codes
100509100768100790101609700737700845701136701278701488701507701646701792702081702174702200702409702470702471702559702695702876702976703944705103705140705151705396705413705506705647705649705652705655705656705658705664705667705669705675705676705677705681705684705702705709705710705717705719705722705724705727705729705732705762705770705776705779705782705789705795
- Amount recalled
- 21756 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was recalled
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.
This product could cause temporary or reversible health problems — stop using it.
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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