Reported Jul 21, 2021 · Ongoing
INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
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?
- INVIVE CRT-P
- Model Numbersa) V172 b) V173 c) V182 d) V183 e) W172 f) W173
- Lot codes and dates
- a) V172
- Serial Numbers
170 of 170 codes
100001100003100008100011100012100026100028100032100036100039100063100066100069100070100078100084100088100094100098100099100103100111100113100116100122100124100128100129100147100156100158100167100168100172100179100185100200100203100207100209100210100211100212100215100220100228100230100232100235100237100240100247100248100249100253100256100257100262100263100274
- Serial Numbers
3,898 of 3,898 codes
100005100008100009100012100015100016100063100064100066100069100077100078100080100084100086100088100090100092100094100096100099100100100101100102100105100112100113100114100118100120100121100122100124100125100129100134100135100136100138100140100144100147100148100150100152100154100155100159100162100165100166100167100171100172100177100178100179100180100181100183
- Amount recalled
- 13332 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.
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