Drug recall
ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021)…
FDA recall event 88107 · Class I · Boston Scientific Corporation
Key facts
| Event ID | 88107 |
|---|---|
| Recall numbers | Z-2015-2021, Z-2016-2021, Z-2017-2021, Z-2018-2021, Z-2019-2021, Z-2020-2021 |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021), INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021), INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021), INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273, INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173 and 1 more |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Jun 3, 2021 |
| Report date | Jul 21, 2021 |
| City | Saint Paul |
| State | MN |
| Country | United States |
| FEI number | 2124215 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: