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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
Recalled February 13, 2019 · FDA recall Z-0796-2019 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Description
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.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →