Medtronic Micra MC1VR01
Medical device recall Z-2493-2019. Published in FDA’s Enforcement Report on Sep 18, 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 Sep 18, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 22244 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?
Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
22244 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN 00643169529731, Serial Numbers: MCR606940S MCR606945S MCR606947S MCR606948S MCR606949S MCR606951S MCR606953S MCR606955S MCR606956S MCR606958S MCR606962S MCR606963S MCR606964S MCR606966S MCR606967S MCR606969S MCR606970S MCR606971S…
Every code shown here, 1,995 characters
GTIN 00643169529731, Serial Numbers: MCR606940S MCR606945S MCR606947S MCR606948S MCR606949S MCR606951S MCR606953S MCR606955S MCR606956S MCR606958S MCR606962S MCR606963S MCR606964S MCR606966S MCR606967S MCR606969S MCR606970S MCR606971S MCR606972S MCR606973S MCR606974S MCR606975S MCR606977S MCR606981S MCR606982S MCR606983S MCR606985S MCR606987S MCR606988S MCR606989S MCR606990S MCR606991S MCR606992S MCR606993S MCR606994S MCR606995S MCR606996S MCR606997S MCR606998S MCR606999S MCR607000S MCR607001S MCR607002S MCR607003S MCR607005S MCR607006S MCR607009S MCR607010S MCR607011S MCR607012S MCR607013S MCR607014S MCR607015S MCR607017S MCR607018S MCR607019S MCR607020S MCR607021S MCR607022S MCR607023S MCR607026S MCR607027S MCR607028S MCR607029S MCR607030S MCR607031S MCR607032S MCR607033S MCR607035S MCR607040S MCR607041S MCR607042S MCR607043S MCR607044S MCR607045S MCR607046S MCR607047S MCR607048S MCR607049S MCR607050S MCR607051S MCR607052S MCR607053S MCR607056S MCR607058S MCR607060S MCR607061S MCR607062S MCR607063S MCR607064S MCR607065S MCR607066S MCR607068S MCR607070S MCR607071S MCR607074S MCR607075S MCR607077S MCR607079S MCR607080S MCR607081S MCR607082S MCR607083S MCR607084S MCR607087S MCR607089S MCR607091S MCR607092S MCR607093S MCR607094S MCR607095S MCR607097S MCR607098S MCR607099S MCR607101S MCR607102S MCR607103S MCR607104S MCR607105S MCR607106S MCR607108S MCR607109S MCR607110S MCR607111S MCR607112S MCR607114S MCR607115S MCR607116S MCR607117S MCR607119S MCR607120S MCR607121S MCR607122S MCR607123S MCR607124S MCR607125S MCR607126S MCR607128S MCR607129S MCR607130S MCR607132S MCR607133S MCR607136S MCR607137S MCR607138S MCR607140S MCR607141S MCR607142S MCR607143S MCR607144S MCR607146S MCR607147S MCR607148S MCR607149S MCR607175S MCR607176S MCR607177S MCR607178S MCR607179S MCR607180S MCR607181S MCR607182S MCR607183S MCR607185S MCR607186S MCR607187S MCR607188S MCR607190S MCR607192S MCR607193S MCR607194S MCR607196S MCR607197S MCR607199S MCR607200S MCR607202S MCR607203S MCR607204S…
FDA’s list runs to 264,340 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?
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 Aug 6, 2019.
- FDA classified it on Sep 9, 2019.
- FDA’s Enforcement Report published it on Sep 18, 2019.
- FDA terminated it on Jun 26, 2023.
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 264,340 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.