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Terminated

MEDTRONIC CARELINK 2090 programmer

FDA Recall Z-0795-2019 · Posted None

Recalling FirmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Recall StatusTerminated
Product CodeOSR
Date Initiated2019-01-17
Date Terminated2021-02-02
Product Quantity33007 units

Reason for Recall

There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its Recommended Replacement Time (RRT).

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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