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

Is my product affected?

MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices

• UPC 00643169763548
• UPC 00643169763593
• UPC 00643169369030
• UPC 00763000156640
• UPC 00763000050986
• UPC 00643169763562
• UPC 00643169167070
• UPC 00643169763555
• UPC 00643169369047
• UPC 00643169763623
• UPC 00643169167025
• UPC 00643169167049
• UPC 00643169167087
• UPC 00643169763609
• UPC 00643169955813

Check against the official notice below — it lists the full affected range.

What happened

Medtronic is recalling the CareLink Encore 29901 programmer system, a prescription device used to interrogate and program implantable medical devices manufactured by Medtronic or Vitatron. Approximately 33,007 units of this device have been distributed across the United States and multiple international locations, including countries in Europe, Asia, and the Middle East. The recall affects specific lot and serial numbers identified in the distribution record.

The record does not specify a remedy or corrective action that affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US, Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic Quantity: 33007 units 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 00643169763593 JVD104342P 00643169763593 JVD104353P 00643169763593 JVD104590P 00763000156640 JVD104617P 00643169763593 JVD104634P 00763000156640 JVD104639P 00763000156640 JVD104650P 00763000156640 JVD104651P 00643169369030 JVD001855P 00643169763593 JVD100565P 00643169763593 JVD100606P 00643169763548 JVD102557P 00643169763548 JVD103186P 00643169763548 JVD103722P 00643169763593 JVD104322P 00643169763593 JVD104330P 00643169763593 JVD104332P 00643169763593 JVD104337P 00763000050986 JVD104344P 00643169763593 JVD104352P 0

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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