Reported Jul 21, 2021 · Ongoing
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284…
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?
- VITALIO DR EL (pacemaker)
- Model Numbersa) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
- Lot codes and dates
- a) J274
- Serial Numbers
349 of 349 codes
100000100001100005100008100009100010100016100017100019100021100026100028100031100032100033100034100036100037100038100041100042100044100045100046100047100049100051100052100055100056100057100060100062100075100084100088100095100098100100100101100102100103100106100107100109100112100114100115100116100118100120100121395016100012100013100018100020100029100030100043
- Serial Numbers
3,720 of 3,720 codes
101302104161100001100002100003100005100007100009100010100011100012100013100014100015100016100020100021100022100024100025100027100028100029100030100031100033100034100035100037100039100040100041100042100044100045100047100049100051100052100057100061100062100071100108100111100130100143100158100240100248100277100313100330100417100421100427100445100450100452100457
- Amount recalled
- 16,525 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.