Reported Jul 21, 2021 · Ongoing
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
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?
- INTUA CRT-P
- Model Numbersa) V272 b) V273 c) W273
- Lot codes and dates
- a) V272
- Serial Numbers
197 of 197 codes
100002100014100017100021100028100037100048100052100053100054100065100067100068100075100077100080100092100093100096100097100098100099100101100104100106100107100108100114100116100118100119100120100124100127100136100152100153100155100159100161100162100165100168100170100171100173100175100176100179100194100195100199100201100202100203100205100206100211100212100216
- Serial Numbers
1,488 of 1,488 codes
100001100002100006100007100013100014100015100017100019100030100032100033100034100035100036100037100038100042100044100045100046100047100048100049100054100056100057100058100060100062100066100067100069100071100072100076100083100084100086100087100088100089100090100091100093100096100097100100100101100103100104100107100116100117100118100119100120100121100123100126
- Serial Numbers
100003100005100009100024100030100037100091100092100093100100100108100109100110100111100112100113100114100115100126100021100118100121100127
- Amount recalled
- 1707 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.