Recall Z-0342-2016 ยท NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Medtronic Inc.
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
| Date | Nov 27, 2015 (initiated Nov 9, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Medtronic sent an Urgent Medical Device Correction letter dated November 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Medtronic records indicate you are following one or more patients with this device. Please see the enclosed Physician/Patient Detail Report. We regret any difficulties this may cause you and your patients. We will continue to monitor device performance and provide regular updates in our product performance report available at wwwp.medtronic.com/productperformance/. Medtronic Patient Services |
| Quantity | 96,787 |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and to Algeria, Argentina, Armenia, Australia, Austria, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.