Recall Z-2017-2021 ยท LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Boston Scientific Corporation
VITALIO DR EL (pacemaker), Model Numbers: a) 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)
| Date | Jul 13, 2021 (initiated Jun 3, 2021) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Device Design |
| Action | The firm issued an advisory communication on June 3, 2021 by letter to the implanting/following physicians and clinics regarding the potential device behavior. The notice included a letter to the patients to be disseminated to the patients implanted with the device at the discretion of the physician. BSC also made the patient letter available on their advisory page, found on our product performance website @ https://www.bostonscientific.com/en-US/pprc/product-advisories.html |
| Quantity | 16,525 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.