Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
Medical device recall Z-0239-2020. 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
- 29544 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: 2090 CareLink Programmer
29544 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: PKK051331R PKK200187R PKK209956R PKK207572R PKK209265R PKK016592R PKK202460R PKK019811R PKK209256R PKK007753R PKK015981R PKK016604R PKK017955R PKK018301R PKK019555R PKK019776R PKK051452R PKK052792R PKK204491R PKK204504R…
Every code shown here, 1,996 characters
Serial Numbers: PKK051331R PKK200187R PKK209956R PKK207572R PKK209265R PKK016592R PKK202460R PKK019811R PKK209256R PKK007753R PKK015981R PKK016604R PKK017955R PKK018301R PKK019555R PKK019776R PKK051452R PKK052792R PKK204491R PKK204504R PKK204551R PKK204575R PKK204595R PKK204640R PKK204740R PKK203409R PKK006360R PKK202461R PKK018408R PKK019864R PKK204483R PKK016046R PKK016047R PKK019820R PKK020201R PKK010563R PKK209937R PKK209928R PKK050581R PKK209305R PKK211241R PKK209294R PKK201567R PKK206687R PKK211282R PKK208961R PKK209373R PKK202996R PKK210858R PKK202566R PKK211233R PKK205628R PKK209203R PKK211710R PKK100124R PKK211042R PKK210807R PKK200224R PKK208864R PKK209197R PKK208958R PKK209332R PKK211720R PKK016352R PKK019371R PKK211286R PKK202507R PKK205997R PKK205974R PKK202465R PKK017835R PKK018895R PKK201637R PKK201640R PKK201643R PKK201645R PKK202394R PKK202397R PKK202411R PKK202428R PKK202441R PKK202444R PKK202451R PKK202454R PKK202459R PKK202463R PKK202464R PKK202466R PKK202489R PKK202494R PKK202521R PKK202550R PKK202552R PKK202553R PKK202557R PKK202558R PKK202561R PKK202563R PKK202564R PKK202565R PKK202567R PKK204964R PKK204973R PKK204974R PKK204983R PKK204985R PKK205962R PKK205968R PKK205970R PKK205977R PKK205979R PKK205982R PKK205986R PKK205989R PKK205994R PKK205998R PKK205999R PKK206000R PKK207397R PKK207399R PKK207576R PKK207588R PKK207601R PKK207603R PKK207604R PKK207606R PKK207607R PKK207615R PKK207621R PKK207622R PKK207623R PKK207628R PKK207649R PKK207650R PKK208500R PKK208503R PKK208508R PKK208510R PKK211023R PKK211064R PKK211072R PKK211084R PKK211100R PKK211227R PKK211228R PKK211229R PKK211235R PKK211238R PKK211239R PKK211284R PKK211289R PKK211294R PKK211339R PKK211342R PKK203579R PKK107297R PKK108724R PKK108726R PKK108729R PKK109569R PKK201389R PKK201402R PKK051032R PKK051031R PKK010204R PKK106139R PKK106149R PKK106153R PKK106161R PKK106164R PKK106212R PKK106221R PKK106224R PKK106228R PKK054839R PKK054899R PKK054903R PKK006109R PKK011161R PKK011162R…
FDA’s list runs to 543,998 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 543,998 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
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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.