Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.

FDA device recall Z-0342-2016 · posted 2015-11-27 · Terminated

Recall details

Recalling firm

Medtronic Inc.

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.

Action taken

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 is available to assist patients at 800-551-5544. Medtronic will offer a supplemental device warranty. Contact your sales representative for terms and conditions. If you have any questions, please contact your local Medtronic Representative or Medtronic Technical Services at 800-505-4636.

Root cause

Device Design

Status

Terminated

Product code

NKE

Quantity affected

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,

Date initiated

2015-11-09

Date posted

2015-11-27

Date terminated

2016-08-24

Location

Saint Paul, MN