FDA Device recall Z-0342-2016
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker
- FDA Device
- Class II
- terminated
- Published 2015-12-09
On 2015-12-09 the FDA classified a Class II recall of Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker by Medtronic, citing medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance. The root cause is unexpected high battery impedance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0342-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-09 |
| Published | 2015-12-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic |
| Distribution | US |
Product
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
Reason
Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance. The root cause is unexpected high battery impedance.
Identifiers
| code_info | Manufactured Serial Numbers PKF100010H PKF100011H PKF100012H PKF100013H PKF100014H PKF100015H PKF100016H PKF10…Manufactured Serial Numbers PKF100010H PKF100011H PKF100012H PKF100013H PKF100014H PKF100015H PKF100016H PKF100018H PKF100019H PKF100020H PKF100021H PKF100022H PKF100023H PKF100024H PKF100025H PKF100026H PKF100027H PKF100028H PKF100029H PKF100030H PKF100031H PKF100032H PKF100033H PKF100034H PKF100035H PKF100036H PKF100037H PKF100038H PKF100039H PKF100040H PKF100041H PKF100042H PKF100043H PKF100044H PKF100045H PKF100046H PKF100047H PKF100048H PKF100049H PKF100050H PKF100051H PKF100052H PKF100053H PKF100054H PKF100055H PKF100056H PKF100057H PKF100058H PKF100059H PKF100060H PKF100061H PKF100062H PKF100063H PKF100064H PKF100065H PKF100066H PKF100067H PKF100068H PKF100069H PKF100070H PKF100071H PKF100072H PKF100073H PKF100074H PKF100075H PKF100076H PKF100077H PKF100078H PKF100079H PKF100080H PKF100081H PKF100082H PKF100083H PKF100084H PKF100085H PKF100086H PKF100087H PKF100088H PKF100089H PKF100090H PKF100091H |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0342-2016%22
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