Recall – Cardiac programmer incorrectly calculates RRT

Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Date of Enforcement Report: 2/1/2019
Class II:

PRODUCT

MEDTRONIC CARELINK 2090 programmer

Recall Number: Z-0795-2019

REASON

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).

RECALLING FIRM/MANUFACTURER

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) on 1/17/2019. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
33007 units

DISTRIBUTION

US Nationwide and International

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.