CLASS II ONGOING Device recall · Reported 28 Dec 2022 · FDA Enforcement Report
HVAD Pump Kit recalled by Heartware
Heartware is recalling HVAD Pump Kit. The recall was initiated on 29 Nov 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0749-2023
- FDA event ID
- 91281
- Recalling firm
- Heartware, Miami Lakes, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Nov 2022
- FDA classified
- 21 Dec 2022
- Reported
- 28 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 29 Nov 2022 | Recall initiated by company | |
| 21 Dec 2022 | Classified by FDA | +22 days |
| 28 Dec 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
Product as listed by the FDA
HeartWare HVAD Pump Kit, REF 1205
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it recalled?
Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
Which lots are affected?
Serial Numbers: HW1412, HW1413, HW1416, HW1433, HW1435, HW1490, HW1493, HW1495, HW1496, HW1593, HW1599, HW1641, HW1661, HW1662, HW1663, HW1664, HW1695, HW1696, HW1698, HW1699, HW1706, HW1708, HW1709, HW1718, HW1727, HW1730, HW1740, HW1741, HW1747, HW1754, HW1760, HW1764, HW1765, HW1768, HW1773, HW1774, HW1777, HW1778, HW1783, HW1785, HW1796, HW1804, HW1808, HW1810, HW1811, HW1815, HW1819, HW1821, HW1822, HW1823, HW1824, HW1825, HW1826, HW1828, HW1830, HW1831, HW1832, HW1839, HW1841, HW1856, HW1857, HW1876, HW1879, HW1882, HW1884, hw1895, HW1896, HW1897, HW1899, HW1900, HW1901, HW1905, HW1906, HW1907, HW1908, HW1913, hw1914, HW1917, HW1920, HW1921, HW1922, HW1923, HW1924, HW1925, HW1926, HW1927, HW1928, HW1929, HW1930, HW1931, HW1933, HW1934, HW1935, HW1936, HW1937, HW1938, HW1939, HW1940, HW1941, HW1942, HW1943, hw1944, HW1947, HW1950, HW1952, HW1960, HW1961, HW1962, HW1964, HW1965, HW1966, HW1967, HW1968, HW1969, HW1970, HW1971, HW1972, HW1973, HW1974, HW1976, HW1977, HW1978, HW1979, HW1983, HW2023, HW2028
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 91281This product is part of a recall event; the main page for the event is HeartWare Model recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | HeartWare Model recalled | Heartware | Other | FL | |
| CLASS II | HVAD Pump Kit recalled by Heartware | Heartware | Other | FL | |
| CLASS II | HeartWare Model recalled | Heartware | Other | FL | |
| CLASS II | HVAD Pump Kit recalled by Heartware | Heartware | Other | FL | |
| CLASS II | HVAD Pump Kit recalled by Heartware | Heartware | Other | FL | |
| CLASS II | HeartWare Model recalled | Heartware | Other | FL | |
| CLASS II | HVAD Pump Kit recalled by Heartware | Heartware | Other | FL |
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