Recall Z-0342-2016— Medtronic Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc., initiated 2015-11-09, terminated 2016-08-24. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Medtronic Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-09
- Terminated
- 2016-08-24
- Firm location
- Saint Paul, MN, United States
Product description
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.