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
Reported: February 10, 2021 Initiated: November 19, 2020 #Z-0946-2021
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.
Details
- Recalling Firm
- Heartware, Inc.
- Units Affected
- 19,562 units
- Distribution
- Worldwide - US Nationwide
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Heartware, Inc.. Units affected: 19,562 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 10, 2021. Severity: Critical. Recall number: Z-0946-2021.
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