Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer
Medical device recall Z-0240-2020. Published in FDA’s Enforcement Report on Nov 6, 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 Nov 6, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Not named no state, in where it went
- 6713 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?
There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer
6713 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: JVD000209P JVD000233P JVD000242P JVD000243P JVD000244P JVD000245P JVD000246P JVD000247P JVD000248P JVD000249P JVD000250P JVD000251P JVD000252P JVD000253P JVD000254P JVD000255P JVD000256P JVD000257P JVD000258P JVD000259P…
Every code shown here, 1,996 characters
Serial Numbers: JVD000209P JVD000233P JVD000242P JVD000243P JVD000244P JVD000245P JVD000246P JVD000247P JVD000248P JVD000249P JVD000250P JVD000251P JVD000252P JVD000253P JVD000254P JVD000255P JVD000256P JVD000257P JVD000258P JVD000259P JVD000260P JVD000261P JVD000262P JVD000263P JVD000264P JVD000265P JVD000266P JVD000267P JVD000269P JVD000270P JVD000271P JVD000272P JVD000273P JVD000274P JVD000275P JVD000276P JVD000277P JVD000278P JVD000279P JVD000280P JVD000281P JVD000282P JVD000283P JVD000284P JVD000285P JVD000286P JVD000287P JVD000288P JVD000289P JVD000290P JVD000291P JVD000292P JVD000293P JVD000294P JVD000295P JVD000297P JVD000298P JVD000299P JVD000300P JVD000301P JVD000302P JVD000303P JVD000304P JVD000305P JVD000306P JVD000307P JVD000308P JVD000309P JVD000310P JVD000311P JVD000312P JVD000313P JVD000314P JVD000315P JVD000316P JVD000317P JVD000318P JVD000319P JVD000320P JVD000321P JVD000322P JVD000323P JVD000324P JVD000325P JVD000326P JVD000327P JVD000328P JVD000329P JVD000330P JVD000331P JVD000332P JVD000333P JVD000334P JVD000335P JVD000336P JVD000337P JVD000338P JVD000339P JVD000340P JVD000341P JVD000342P JVD000343P JVD000344P JVD000345P JVD000346P JVD000347P JVD000348P JVD000349P JVD000350P JVD000351P JVD000352P JVD000353P JVD000354P JVD000355P JVD000356P JVD000357P JVD000359P JVD000360P JVD000361P JVD000362P JVD000363P JVD000364P JVD000365P JVD000366P JVD000367P JVD000368P JVD000369P JVD000370P JVD000371P JVD000372P JVD000373P JVD000374P JVD000375P JVD000376P JVD000377P JVD000378P JVD000379P JVD000380P JVD000381P JVD000382P JVD000383P JVD000384P JVD000385P JVD000386P JVD000387P JVD000388P JVD000389P JVD000390P JVD000391P JVD000392P JVD000393P JVD000394P JVD000395P JVD000396P JVD000397P JVD000398P JVD000399P JVD000400P JVD000401P JVD000402P JVD000403P JVD000404P JVD000405P JVD000406P JVD000407P JVD000408P JVD000409P JVD000410P JVD000411P JVD000412P JVD000413P JVD000414P JVD000415P JVD000416P JVD000417P JVD000418P JVD000419P JVD000420P JVD000421P JVD000422P…
FDA’s list runs to 95,414 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.
Worldwide Distribution
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Oct 3, 2019.
- FDA classified it on Oct 29, 2019.
- FDA’s Enforcement Report published it on Nov 6, 2019.
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 95,414 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.