Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0795-2019·Announced 2019-02-13

Medtronic CareLink 2090 Programmer Recalled for Longevity Display Error

Medtronic is recalling CareLink 2090 programmers because they may incorrectly display the remaining longevity value for up to two years before the device reaches its Recommended Replacement Time.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class II recall. The source text describes a display calculation error without reporting any injuries, illnesses, or deaths, which aligns with the Moderate severity criteria for low-risk issues or voluntary precautionary actions where harm is not explicitly reported.

Plain-English summary

Medtronic Inc. is recalling the MEDTRONIC CARELINK 2090 programmer. The recall involves 33,007 units distributed in the United States and 18 other countries, including Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, and the Syrian Arab Republic.

The recall is due to an error in how the programmer calculates and displays the remaining longevity value. This error can occur during a period of time, up to two years, prior to the implanted device reaching its Recommended Replacement Time (RRT). The source text does not specify whether this error leads to incorrect clinical decisions or patient harm.

Healthcare providers and patients using the affected programmer should contact Medtronic for instructions on how to address the display error. The recall number is Z-0795-2019.

The recalled product

Product: MEDTRONIC CARELINK 2090 programmer
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Cardiac Rhythm Management
Hazard: display-error
data-integrity
Affected units: 33,007

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

See all →

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