Recall Z-0795-2019— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2019-01-17, terminated 2021-02-02. FDA's recall record names no specific 510(k) clearance for this event. Product: MEDTRONIC CARELINK 2090 programmer. 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
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-01-17
- Terminated
- 2021-02-02
- Firm location
- Mounds View, MN, United States
Product description
MEDTRONIC CARELINK 2090 programmer
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.