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.
What this means for you
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
- Hazard
- 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.
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