MEDTRONIC CARELINK 2090 programmer
Reported: February 13, 2019 Initiated: January 17, 2019 #Z-0795-2019
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).
Details
- Recalling Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Units Affected
- 33007 units
- Distribution
- US, Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic
- Location
- Mounds View, MN
Frequently Asked Questions
What product was recalled? ▼
MEDTRONIC CARELINK 2090 programmer. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 33007 units.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 13, 2019. Severity: Moderate. Recall number: Z-0795-2019.
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