Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices

Recall date

January 17, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0796-2019

FDA classification

Class II

Brand / firm

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

Sold / distributed

US, Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices