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

Hazard / Issue

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.

Issued by

FDA

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

Lot/Code Info: UPN Lot Serial # 00643169763548 JVD101565P 00643169763548 JVD101641P 00643169763593 JVD102984P 00643169763593 JVD103032P 00643169763593 JVD103329P 00643169763593 JVD103735P 00643169763593 JVD104028P 00643169763593 JVD104036P 00643169763593 JVD104051P 00643169763593 JVD104100P 00643169369030 JVD002238P 00643169369030 JVD002367P 00643169369030 JVD002630P 00643169763593 JVD100423P 00643169763593 JVD100558P 00643169763548 JVD100793P 00643169763548 JVD101197P 00643169763548 JVD101399P 00643169763548 JVD102238P 00643169763548 JVD102630P 00643169763548 JVD102774P 00643169763548 JVD103626P 00643169763548 JVD103741P 00643169763548 JVD103830P 00643169763593 JVD103921P 00643169763593 JVD104107P 00643169763593 JVD104453P 00643169763593 JVD104483P 00643169763593 JVD104484P 00643169763593 JVD104486P 00643169763593 JVD104487P 00643169763548 JVD100130P 00643169763593 JVD100637P 00643169763593 JVD101248P 00643169763593 JVD102969P 00643169763593 JVD103661P 00643169763593 JVD103670P 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