RecallRadar

FDA Device recall Z-0796-2019

MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices

On 2019-02-13 the FDA classified a Class II recall of MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing the Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. P….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0796-2019
ClassificationClass II
Statusterminated
Initiated2019-01-17
Published2019-02-13
Last updated2026-09-13 11:55 UTC
CompanyMedtronic Cardiac Rhythm And Heart Failure Crhf
DistributionGA

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.

Identifiers

code_info
UPN Lot Serial # 00643169763548 JVD101565P 00643169763548 JVD101641P 00643169763593 JVD102984P 00643169763593 JVD10…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 0064316976

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0796-2019%22

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