Recall Z-0796-2019— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2019-01-17, terminated 2021-02-02. FDA's recall record names no specific 510(k) clearance for this event. Product: MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices. Reason: 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..

Recalling firm

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

Classification

Class II

Status

Terminated

Initiated

2019-01-17

Terminated

2021-02-02

Firm location

Mounds View, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.