Reported Jul 21, 2021 · Ongoing
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
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 Bldg 3 · Saint Paul, MN · 55112-5700
Is this the product you have?
- INLIVEN CRT-P
- Model Numbersa) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
- Lot codes and dates
- a) V284
- Serial Numbers
100002100000100003100005100009100010100011100012100014100015100016100017100018100019100022100023100027100029234350234352 b) V285
- Serial Numbers
430 of 430 codes
246521100000100002100007100018100026100036100059100065100087100097100101100111100117100126100127100136100139100141100154100156100158100159100161100162100163246441246442246446246447246449246451246453246458246459246463246469246470246471246472246473246474246475246477246481246483246484246485246486246495246496246497246499246500246501246503246504246505246506246508
- Serial Numbers
178 of 178 codes
111154111189111247111112111113111114111115111118111119111120111121111122111124111125111127111128111131111133111134111136111138111139111140111142111143111144111145111147111148111149111150111151111152111155111158111159111163111164111165111166111167111168111169111171111173111174111175111176111177111180111181111184111185111186111187111188111191111192111193111195
- Serial Numbers
3,006 of 3,006 codes
111149111152111164111166111178111189111190111207111217111218111230111256111287111310111321111363111373111379111394111397111405111407111417111423111441111466111472111484111486111489111516111519111524111536111545111559111566111593111609111613111692111703111709111765111773111820111826111842111883111959111974111991112097112159112165112194112226112284112367112459
- Amount recalled
- 3634 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
Stop using this product now
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population
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.
Free recall alerts
Get alerted about new Boston Scientific Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.