CareLink SmartSync Device Manager
Medical device recall Z-2505-2020. Published in FDA’s Enforcement Report on Jul 15, 2020.
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 Jul 15, 2020. 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
- 2773 devices 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 rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management”, Atrial Lead Position Check”, EffectivCRT” algorithms, and AdaptivCRT”). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CareLink SmartSync Device Manager, Model Number 24970A
2773 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
serial numbers: SPM001078A SPM001117A SPM001120A SPM001139A SPM001140A SPM001141A SPM001174A SPM001231A SPM001250A SPM001251A SPM001252A SPM001253A SPM001262A SPM001265A SPM001266A SPM001270A SPM001281A SPM001284A SPM001285A SPM001363A…
Every code shown here, 1,996 characters
serial numbers: SPM001078A SPM001117A SPM001120A SPM001139A SPM001140A SPM001141A SPM001174A SPM001231A SPM001250A SPM001251A SPM001252A SPM001253A SPM001262A SPM001265A SPM001266A SPM001270A SPM001281A SPM001284A SPM001285A SPM001363A SPM001377A SPM001394A SPM001396A SPM001398A SPM001403A SPM001404A SPM001407A SPM001419A SPM001424A SPM001425A SPM001441A SPM001445A SPM001449A SPM001456A SPM001463A SPM001465A SPM001474A SPM001477A SPM001478A SPM001482A SPM001484A SPM001486A SPM001491A SPM001519A SPM001544A SPM001545A SPM001552A SPM001554A SPM001555A SPM001556A SPM001557A SPM001559A SPM001560A SPM001561A SPM001562A SPM001571A SPM001581A SPM001584A SPM001587A SPM001588A SPM001633A SPM001659A SPM001660A SPM001661A SPM001662A SPM001663A SPM001664A SPM001665A SPM001666A SPM001667A SPM001668A SPM001669A SPM001670A SPM001671A SPM001672A SPM001673A SPM001674A SPM001675A SPM001676A SPM001677A SPM001683A SPM001684A SPM001685A SPM001686A SPM001704A SPM001705A SPM001706A SPM001707A SPM001709A SPM001710A SPM001711A SPM001712A SPM001713A SPM001714A SPM001715A SPM001716A SPM001719A SPM001720A SPM001721A SPM001723A SPM001732A SPM001733A SPM001734A SPM001735A SPM001738A SPM001739A SPM001745A SPM001746A SPM001747A SPM001748A SPM001749A SPM001751A SPM001753A SPM001754A SPM001756A SPM001759A SPM001760A SPM001766A SPM001771A SPM001774A SPM001775A SPM001776A SPM001779A SPM001781A SPM001782A SPM001784A SPM001786A SPM001787A SPM001793A SPM001795A SPM001796A SPM001798A SPM001799A SPM001800A SPM001802A SPM001803A SPM001805A SPM001806A SPM001807A SPM001808A SPM001809A SPM001812A SPM001813A SPM001816A SPM001817A SPM001818A SPM001842A SPM001846A SPM001875A SPM001878A SPM001880A SPM001883A SPM001884A SPM001885A SPM001889A SPM001896A SPM001901A SPM001929A SPM001935A SPM001936A SPM001961A SPM001967A SPM001971A SPM001973A SPM001974A SPM001975A SPM001976A SPM001977A SPM001982A SPM001983A SPM001984A SPM001985A SPM001986A SPM001988A SPM001989A SPM002001A SPM002005A SPM002024A SPM002035A SPM002041A…
FDA’s list runs to 30,519 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
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 Jun 4, 2020.
- FDA classified it on Jul 5, 2020.
- FDA’s Enforcement Report published it on Jul 15, 2020.
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 30,519 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.