HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Recall
- Recall Number
- Z-1266-2022
- Event Number
- 90228
- Firm
- Medtronic Inc
- FEI Number
- 3001504994
- Product Code
- DSQ
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- May 5, 2022
- Address
- 710 Medtronic Pkwy, Mailstop Ls245, Minneapolis, MN, 55432-5603
Description
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
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.
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 patients to always keep two sources of power connected to their controller and have fully charged spare batteries available at all times. If a [Power Disconnect] alarm occurs while a battery is physically connected, that battery should be taken out of service. The letter references instructions from the patient manual. The consignee actions included immediately identifying and quarantining all affected batteries listed in the attachment; immediately notify patients with affected batteries that Medtronic is conducting this retrieval and have them remove these batteries from service; informed the consignee that the Medtronic Field Representative can assist them in the return of the affected product; complete and return the enclosed Customer Confirmation Form and follow the instructions to initiate an exchange; and share the letter with all those who need to be aware within their organization or to any organization where the affected batteries have been transferred.
Worldwide Distribution. US nationwide, Austria, Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, New Zealand, North Macedonia, Norway, Poland, Spain, Switzerland, and the United Kingdom.
429 batteries