Reported Jul 14, 2021 · Ongoing
VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
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?
- VALITUDE CRT-P pacemaker
- Modelsa) U125 b) U128
- Lot codes and dates
- a) U125
- Serial Numbers
524 of 524 codes
100009100057100074100257100521700037700061700068700074700172700179700190700253702556702777702999703683703806704048707332707470707508100002100003100004100005100006100007100008100010100011100013100015100020100024100026100028100029100033100050100054100058100062100063100066100067100068100069100071100076100079100081100084100085100086100091100102100106100110100133
- Serial Numbers
3,545 of 3,545 codes
100184100187100217100222100236100240100247100251100253100256100260100262100274100275100277100289100308100317100328100330100331100338100339100346100350100351100355100357100359100361100363100364100369100371100372100373100376100377100378100379100380100381100383100386100389100390100391100392100393100394100397100399100400100401100402100404100405100409100410100411
- Amount recalled
- 6377 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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