MEDTRONIC CARELINK 2090 programmer
Medical device recall Z-0795-2019. 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?
There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its Recommended Replacement Time (RRT).
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
MEDTRONIC CARELINK 2090 programmer
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 # 00613994175397 PKK005256R 00721902246241 PKK005435R 00613994175380 PKK010235R 00613994136541 PKK010864R 00613994175106 PKK010944R 00613994175106 PKK013390R 00613994175076 PKK014053R 00721902171079 PKK014459R 00721902246241…
Every code shown here, 1,993 characters
UPN Lot Serial # 00613994175397 PKK005256R 00721902246241 PKK005435R 00613994175380 PKK010235R 00613994136541 PKK010864R 00613994175106 PKK010944R 00613994175106 PKK013390R 00613994175076 PKK014053R 00721902171079 PKK014459R 00721902246241 PKK016196R 00613994581594 PKK019007R 00613994175397 PKK053072R 00613994175397 PKK053799R 00885074314921 PKK100200R 00885074301440 PKK100970R 00885074312873 PKK101320R 00885074312866 PKK101390R 00885074312873 PKK101826R 00613994175144 PKK102639R 00885074313122 PKK104915R 00613994175250 PKK106350R 00613994434982 PKK200802R 00613994435309 PKK200982R 00613994435309 PKK201102R 00613994434937 PKK203476R 00613994434937 PKK203505R 00613994580894 PKK204058R 00613994580962 PKK204433R 00613994580887 PKK205733R 00613994580924 PKK205784R 00613994580894 PKK206708R 00613994580962 PKK206741R 00613994580962 PKK206743R 00613994581532 PKK210147R 00613994581532 PKK210150R 00613994581532 PKK210151R 00613994581532 PKK210155R 00613994581532 PKK210158R 00613994581532 PKK210163R 00613994581532 PKK210176R 00613994581532 PKK210181R 00613994581532 PKK210182R 00613994581532 PKK210198R 00613994581532 PKK210214R 00613994581532 PKK210216R 00613994581532 PKK210218R 00613994581532 PKK210220R 00613994581532 PKK210224R 00613994581532 PKK210232R 00613994581532 PKK210237R 00613994136527 PKK001974R 00613994581594 PKK002535R 00613994136527 PKK003022R 00613994175397 PKK003119R 00613994136527 PKK003178R 00613994175397 PKK003609R 00613994175120 PKK003704R 00721902171079 PKK003875R 00613994581594 PKK004084R 00613994175397 PKK004136R 00613994581594 PKK004684R 00613994175397 PKK004718R 00613994581594 PKK005160R 00613994136527 PKK005803R 00613994175076 PKK006004R 00613994581594 PKK006085R 00613994175106 PKK006330R 00613994175397 PKK006820R 00613994175076 PKK010374R 00721902171079 PKK011150R 00721902171079 PKK011426R 00613994175076 PKK011663R 00613994175397 PKK012560R 00721902246234 PKK012936R 00721902171239 PKK013729R 00613994136527 PKK013997R 00613994175076 PKK014411R…
FDA’s list runs to 1,228,810 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 1,228,810 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.