FDA Device recall Z-2020-2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
- FDA Device
- Class I
- ongoing
- Published 2021-07-21
On 2021-07-21 the FDA classified a Class I recall of INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021) 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-2020-2021 |
| 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
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
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) V284, Serial Numbers: 100002, 100000, 100003, 100005, 100009, 100010, 100011, 100012, 100014, 100015, 100016, 100017…a) V284, Serial Numbers: 100002, 100000, 100003, 100005, 100009, 100010, 100011, 100012, 100014, 100015, 100016, 100017, 100018, 100019, 100022, 100023, 100027, 100029, 234350, 234352 b) V285, Serial Numbers: 246521, 100000, 100002, 100007, 100018, 100026, 100036, 100059, 100065, 100087, 100097, 100101, 100111, 100117, 100126, 100127, 100136, 100139, 100141, 100154, 100156, 100158, 100159, 100161, 100162, 100163, 246441, 246442, 246446, 246447, 246449, 246451, 246453, 246458, 246459, 246463, 246469, 246470, 246471, 246472, 246473, 246474, 246475, 246477, 246481, 246483, 246484, 246485, 246486, 246495, 246496, 246497, 246499, 246500, 246501, 246503, 246504, 246505, 246506, 246508, 246509, 246512, 246519, 246520, 246521, 246527, 246529, 246532, 246534, 246542, 246546, 246549, 246554, 246577, 246586, 246590, 246591, 246592, 246593, 246596, 246598, 246610, 246611, 246613, 246619, 246623, 246627, 246628, 246630, 246634, 246636, 246637, 246645, 246646, 246647, 246650, 246654, 246656, 24665 |
|---|
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-2020-2021%22
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