Reported Jul 14, 2021 · Ongoing
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
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?
- Accolade pacemaker
- Modelsa) L300 b) L301 c) L310 d) L311 e) L321 f) L331
- Lot codes and dates
- a) L300
- Serial Numbers
336 of 336 codes
712118713277713352713357713365713381713390713398713403713405713406713420713440713443713447713454713456713459713461713464713469713470713474713480713483713500713501713506713508713513713515713516713519713528713530713538713542713543713544713548713592713593713614713621713624713625713630713631713633713637713642713646713649713650713651713652713666713669713675713682
- Serial Numbers
3,733 of 3,733 codes
100547100752100822100829100843100845100846100850100852100853100857100863100865100866100867100868100869100870100871100874100875100876100878100879100881100883100884100889100890100891100892100893100894100895100896100897100899100900100903100904100911100912100913100914100915100916100919100920100921100923100925100926100927100928100929100930100931100932100936100937
- Amount recalled
- 70074 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.
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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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