Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager
Medical device recall Z-0241-2020. 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
- 874 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: CareLink SmartSync Device Manager
874 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: SPM001018A SPM001019A SPM001020A SPM001021A SPM001022A SPM001023A SPM001024A SPM001025A SPM001026A SPM001027A SPM001028A SPM001029A SPM001030A SPM001031A SPM001032A SPM001033A SPM001034A SPM001035A SPM001036A SPM001037A…
Every code shown here, 1,996 characters
Serial Numbers: SPM001018A SPM001019A SPM001020A SPM001021A SPM001022A SPM001023A SPM001024A SPM001025A SPM001026A SPM001027A SPM001028A SPM001029A SPM001030A SPM001031A SPM001032A SPM001033A SPM001034A SPM001035A SPM001036A SPM001037A SPM001038A SPM001039A SPM001040A SPM001041A SPM001042A SPM001043A SPM001044A SPM001045A SPM001046A SPM001047A SPM001078A SPM001079A SPM001080A SPM001081A SPM001082A SPM001083A SPM001084A SPM001085A SPM001086A SPM001087A SPM001092A SPM001093A SPM001094A SPM001096A SPM001097A SPM001098A SPM001100A SPM001101A SPM001102A SPM001103A SPM001105A SPM001106A SPM001107A SPM001108A SPM001109A SPM001110A SPM001111A SPM001112A SPM001113A SPM001114A SPM001117A SPM001118A SPM001119A SPM001120A SPM001121A SPM001122A SPM001123A SPM001124A SPM001125A SPM001128A SPM001130A SPM001131A SPM001132A SPM001133A SPM001134A SPM001136A SPM001137A SPM001138A SPM001139A SPM001140A SPM001141A SPM001142A SPM001143A SPM001144A SPM001145A SPM001146A SPM001149A SPM001150A SPM001151A SPM001152A SPM001153A SPM001154A SPM001155A SPM001156A SPM001157A SPM001158A SPM001159A SPM001160A SPM001161A SPM001162A SPM001166A SPM001167A SPM001168A SPM001169A SPM001170A SPM001171A SPM001172A SPM001174A SPM001217A SPM001218A SPM001219A SPM001220A SPM001221A SPM001227A SPM001228A SPM001229A SPM001230A SPM001231A SPM001232A SPM001233A SPM001234A SPM001235A SPM001236A SPM001237A SPM001238A SPM001239A SPM001240A SPM001241A SPM001242A SPM001243A SPM001244A SPM001245A SPM001246A SPM001247A SPM001248A SPM001249A SPM001252A SPM001253A SPM001254A SPM001255A SPM001256A SPM001257A SPM001258A SPM001259A SPM001260A SPM001261A SPM001262A SPM001263A SPM001264A SPM001265A SPM001266A SPM001267A SPM001268A SPM001269A SPM001270A SPM001271A SPM001272A SPM001273A SPM001274A SPM001275A SPM001276A SPM001277A SPM001278A SPM001279A SPM001280A SPM001282A SPM001283A SPM001284A SPM001285A SPM001286A SPM001287A SPM001288A SPM001289A SPM001290A SPM001291A SPM001292A SPM001293A SPM001294A SPM001295A SPM001296A…
FDA’s list runs to 47,151 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 47,151 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.