Recall Z-0946-2021— Heartware, Inc.
Class I · Ongoing
Class I FDA medical device recall by Heartware, Inc., initiated 2020-11-19. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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 at a rate substantially higher than pump in the overall population..
- Recalling firm
- Heartware, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2020-11-19
- Firm location
- Miami Lakes, FL, United States
Product description
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
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 at a rate substantially higher than pump in the overall population.
Data sourced from openFDA. This site is unofficial and independent of the FDA.