Drug recall
ACCOLADE DR Pacemaker
FDA recall event 78787 · Class II · Boston Scientific Corporation
Key facts
| Event ID | 78787 |
|---|---|
| Recall numbers | Z-0354-2018, Z-0355-2018, Z-0356-2018, Z-0357-2018, Z-0358-2018, Z-0359-2018, Z-0360-2018, Z-0361-2018, Z-0362-2018, Z-0363-2018, Z-0364-2018, Z-0365-2018 and 12 more |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | ACCOLADE DR Pacemaker, ACCOLADE EL DR Pacemaker, ACCOLADE MRI DR Pacemaker, ACCOLADE MRI EL DR Pacemaker, ACCOLADE MRI SR Pacemaker and 19 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy… |
| Initiation date | Dec 7, 2017 |
| Report date | Jan 24, 2018 |
| City | Saint Paul |
| State | MN |
| Country | United States |
| FEI number | 2124215 |
At a glance
- 10–99 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: