Recall of Medtronic CareLink 29901 programmer for Medtronic and Vitaron devices. The device must be used only by trained personnel for programming implantable medical devices to avoid risks.
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.
Medtronic is recalling its CareLink Encore 29901 programmer system for use with Medtronic and Vitaron implantable devices. The device must be used only by trained personnel following specific technical guidelines to avoid risks of improper use.
The CareLink 29901 programmer system is designed for use by trained personnel to program implantable medical devices. Improper use without proper training and technical guidance could lead to incorrect device programming, potentially causing health risks.
Patients with Medtronic or Vitaron implantable cardiac devices who use the CareLink 29901 programmer system. Healthcare professionals who program these devices are at higher risk.
Check for the CareLink Encore 29901 programmer with the UPN Lot Serial numbers listed in the recall (e.g., 00643169763548 JVD101565P).
Look for the UPN Lot Serial numbers listed in the recall (e.g., 00643169763548 JVD101565P) on your CareLink Encore 29901 programmer.
The CareLink Encore 29901 programmer is safe only when used by trained personnel following the technical guidelines and manufacturer instructions.
No, but only trained personnel should use it following the technical guidelines to avoid risks.
Check the UPN Lot Serial numbers listed in the recall to determine if your device is affected.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0796-2019 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0796-2019 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
