Reported Jul 14, 2021 · Ongoing
VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
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?
- VISIONIST CRT-P pacemaker
- Modelsa) U225 b) U226 c) U228
- Lot codes and dates
- a) U225
- Serial Numbers
1,507 of 1,507 codes
707340100094100142100152100160100184100309100364100807100880100908100913700015700197700469700559700563700576700586700598700613700655700681700682700722700725700782700824700895700942700961700998701017701030701045701094701118701127701212701230701264701336701339701343701407701477701504702448702462702471702654702673702685702809703137703696703697703784703827703875
- Serial Numbers
273 of 273 codes
100044100069100116700077700093700140700163700220700306700323700331100006100009100011100012100013100014100015100016100017100018100019100021100022100023100024100025100026100027100028100029100030100032100034100035100038100039100042100045100046100048100049100050100052100055100058100059100060100061100062100063100066100067100068100070100072100073100074100075100076
- Serial Numbers
2,286 of 2,286 codes
702970726570100020100024100048100074100080100127100129100211100225100230100255100299100496101262101351101386101531101620101741101787101800101883101896101910101982102125102224102298700031700063700124700151700220700234700238700294700403700704700931701037701243701353701496701866701912701959702057702434702597702602702651702839703191703259703318703362703363703962
- Amount recalled
- 5920 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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