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Terminated

MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices

FDA Recall Z-0796-2019 · Posted None

Recall StatusTerminated
Product CodeOSR
Date Initiated2019-01-17
Date Terminated2021-02-02
Product Quantity33007 units

Reason for Recall

The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the appropriate programmer software and implantable device technical manuals for more information related to specific implantable device models. Programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the implantable device and after careful determination of appropriate parameter values based on the patient's condition and pacing system used. The Medtronic CareLink Encore 29901 programmer must be used only for programming implantable devices manufactured by Medtronic or Vitatron.

Firm Action

In the US, beginning 17-Jan-2019, Medtronic Field Representatives hand delivered a courtesy FCA Notification Letter to consignees who, according to Medtronic records, have programmers that are eligible for Micra software updates. Field Representatives will update the identified programmers using a provided USB. Notification will also be hand delivered to Micra Implanting or Follow-up physicians for awareness of the issue.

Root Cause

Software design

Distribution Pattern

US, Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic

Official Source

View FDA Recall →

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

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