FDA Device recall Z-2018-2021
INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
- FDA Device
- Class I
- ongoing
- Published 2021-07-21
On 2021-07-21 the FDA classified a Class I recall of INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173 by Boston Scientific, citing 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 Expl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2018-2021 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-06-03 |
| Published | 2021-07-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
Product
INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
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 family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population
Identifiers
| code_info | a) V172, Serial Numbers: 100001, 100003, 100008, 100011, 100012, 100026, 100028, 100032, 100036, 100039, 100063, 1000…a) V172, Serial Numbers: 100001, 100003, 100008, 100011, 100012, 100026, 100028, 100032, 100036, 100039, 100063, 100066, 100069, 100070, 100078, 100084, 100088, 100094, 100098, 100099, 100103, 100111, 100113, 100116, 100122, 100124, 100128, 100129, 100147, 100156, 100158, 100167, 100168, 100172, 100179, 100185, 100200, 100203, 100207, 100209, 100210, 100211, 100212, 100215, 100220, 100228, 100230, 100232, 100235, 100237, 100240, 100247, 100248, 100249, 100253, 100256, 100257, 100262, 100263, 100274, 100275, 100285, 100295, 100296, 100299, 100301, 100302, 100305, 100306, 100308, 100319, 100320, 100322, 100324, 100326, 100329, 100330, 100331, 100333, 100343, 100344, 100346, 100351, 100353, 100355, 100359, 100364, 100376, 100381, 100383, 100384, 100403, 100405, 100411, 100413, 100417, 100422, 100423, 100425, 100427, 100437, 100447, 100454, 100456, 100457, 100468, 100474, 100475, 100477, 100478, 100481, 100482, 100488, 100493, 100499, 100506, 100508, 100512, 100518, 100520, 100533, 10053 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2018-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.