FDAJanuary 17, 2019device

MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the appropriate programmer software and implantable device technical manuals for more information related to specific implantable device models. Programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the implantable device and after careful determination of appropriate parameter values based on the patient's condition and pacing system used. The Medtronic CareLink Encore 29901 programmer must be used only for programming implantable devices manufactured by Medtronic or Vitatron.

What to do

FDA enforcement status: Terminated

Brands named

medtronic inc cardiac rhythm and heart failure crhfmedtronicmedtronic inc

UPCs

006431697635480064316976359300643169369030007630001566400076300005098600643169763562006431691670700064316976355500643169369047006431697636230064316916702500643169167049

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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