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Terminated

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

FDA Recall Z-0342-2016 · Posted 2015-11-27

Recalling FirmMedtronic Inc.
Recall StatusTerminated
Product CodeNKE
Date Initiated2015-11-09
Date Terminated2016-08-24
Product Quantity96,787

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.

Firm 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 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

Distribution Pattern

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, Egypt, El Salvador, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary , India, Indonesia, Iran, Ireland, Israel, Italy, Japan Jordan, Kazakhstan, Kenya, Kuwait, Korea, Latvia, Luxembourg, Lebanon, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius , Mexico, Morocco, Netherlands, New Zealand, Norway,Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Trinidad, Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Vietnam.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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