Recall Z-1266-2022 ยท DSQ Ventricular (Assist) Bypass
Medtronic Inc
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
| Date | May 5, 2022 |
| Status | Open, Classified |
| Reason | Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete charge or properly recharging. |
| Root cause | Process control |
| Action | In the United States, on 5/5/2022, a written Medical Device Retrieval letter dated May 2022 was mailed via 2-day UPS delivery to consignees who have received potentially affected product according to Medtronic records. Outside of the US (OUS), beginning 5/5/2022, an Urgent Medical Device Retrieval letter was being delivered via regionally approved methods to consignees who have received potentially affected product according to Medtronic records. The letter notified customers of the issue description and were provided patient management recommendations. This included reminding their patien |
| Quantity | 429 batteries |
| Distribution | Worldwide Distribution. US nationwide, Austria, Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, New Zealand, North Macedonia, Norway, Poland, Spain, Switzerland, and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.