MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
Medical device recall Z-0796-2019. Published in FDA’s Enforcement Report on Feb 13, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 13, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Georgia the one state its words name
- 33007 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
33007 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UPN Lot Serial # 00643169763548 JVD101565P 00643169763548 JVD101641P 00643169763593 JVD102984P 00643169763593 JVD103032P 00643169763593 JVD103329P 00643169763593 JVD103735P 00643169763593 JVD104028P 00643169763593 JVD104036P 00643169763593…
Every code shown here, 1,993 characters
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 00643169763593 JVD104384P 00643169763593 JVD104387P 00643169763593 JVD104523P 00643169763593 JVD104529P 00643169763593 JVD104541P 00643169763593 JVD104543P 00643169763593 JVD104545P 00643169763593 JVD104546P 00643169763593 JVD104557P 00643169763593 JVD104560P 00643169763593 JVD104564P 00643169763593 JVD104565P 00643169763593 JVD104567P 00643169763562 JVD104568P 00643169763593 JVD104569P 00643169763593 JVD104571P 00643169763593 JVD104572P 00643169763593 JVD104574P 00643169763593 JVD104575P…
FDA’s list runs to 195,792 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US, Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic
The states and territories these words name
- Georgia
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 17, 2019.
- FDA classified it on Feb 1, 2019.
- FDA’s Enforcement Report published it on Feb 13, 2019.
- FDA terminated it on Feb 2, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), of Mounds View, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 195,792 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.