Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0796-2019·Announced 2019-02-13

Medtronic CareLink Encore 29901 Programmer Recalled for Usage Restrictions

Medtronic is recalling CareLink Encore 29901 programmers to ensure they are used only for Medtronic or Vitatron implantable devices by trained personnel.

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 recall is classified as FDA Class II, and the source text describes usage restrictions and training requirements rather than a specific defect causing reported injuries or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Medtronic Inc. is recalling the Medtronic CareLink Encore 29901 programmer system. This device is a prescription medical device indicated for the interrogation and programming of implantable medical devices.

The recall is initiated to ensure the device is used strictly according to its intended specifications. The programmer must be used only for programming implantable devices manufactured by Medtronic or Vitatron. Additionally, programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the specific implantable device and after determining appropriate parameter values based on the patient's condition and pacing system.

Affected units were distributed in the US 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. Users should refer to the Programmer Reference Guide and appropriate technical manuals before use.

The recalled product

Product: MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Cardiac Rhythm Management
Hazard: misuse
improper-usage
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)

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