Drug recall
Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e…
FDA recall event 86924 · Class I · Heartware, Inc.
Key facts
| Event ID | 86924 |
|---|---|
| Recall numbers | Z-0946-2021 |
| Recalling firm | Heartware, Inc. |
| Product type | Devices |
| Products | Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts… |
| Initiation date | Nov 19, 2020 |
| Report date | Feb 10, 2021 |
| City | Miami Lakes |
| State | FL |
| Country | United States |
| FEI number | 3007042319 |
At a glance
- 1–9 Products in this recall
- 1–9 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: