Medtronic Micra MC1VR01, Single chamber transcatheter pacing system
Medical device recall Z-2492-2019. 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
- 24521 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, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
24521 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
REF MC1VR01US, GTIN 00643169529748, Serial Numbers: MCR610462S MCR610483S MCR610486S MCR610498S MCR610503S MCR610514S MCR610516S MCR610517S MCR610523S MCR610525S MCR610526S MCR610527S MCR610529S MCR610533S MCR610537S MCR610538S MCR610542S…
Every code shown here, 1,999 characters
REF MC1VR01US, GTIN 00643169529748, Serial Numbers: MCR610462S MCR610483S MCR610486S MCR610498S MCR610503S MCR610514S MCR610516S MCR610517S MCR610523S MCR610525S MCR610526S MCR610527S MCR610529S MCR610533S MCR610537S MCR610538S MCR610542S MCR610543S MCR610546S MCR610547S MCR610551S MCR610554S MCR610555S MCR610556S MCR610557S MCR610567S MCR610569S MCR610570S MCR610571S MCR610572S MCR610577S MCR610579S MCR610582S MCR610583S MCR610584S MCR610586S MCR610587S MCR610592S MCR610593S MCR610595S MCR610598S MCR610599S MCR610600S MCR610605S MCR610608S MCR610614S MCR610615S MCR610618S MCR610635S MCR610642S MCR610643S MCR610645S MCR610646S MCR610647S MCR610649S MCR610653S MCR610655S MCR610656S MCR610657S MCR610659S MCR610669S MCR610677S MCR610689S MCR610690S MCR610692S MCR610697S MCR610709S MCR610713S MCR610715S MCR610844S MCR610846S MCR610849S MCR610852S MCR610857S MCR610860S MCR610870S MCR610872S MCR610877S MCR610878S MCR610883S MCR610944S MCR610947S MCR610953S MCR610959S MCR610961S MCR610962S MCR610966S MCR610967S MCR610972S MCR610976S MCR610977S MCR610983S MCR610985S MCR610986S MCR610990S MCR610991S MCR610992S MCR610994S MCR610996S MCR610997S MCR610998S MCR611039S MCR611044S MCR611210S MCR611214S MCR611218S MCR611220S MCR611222S MCR611224S MCR611225S MCR611231S MCR611234S MCR611239S MCR611242S MCR611248S MCR611252S MCR611260S MCR611266S MCR611275S MCR611276S MCR611290S MCR611298S MCR611309S MCR611315S MCR611316S MCR611321S MCR611324S MCR611325S MCR611330S MCR611336S MCR611337S MCR611342S MCR611344S MCR611346S MCR611347S MCR611355S MCR611356S MCR611357S MCR611359S MCR611361S MCR611362S MCR611363S MCR611365S MCR611369S MCR611375S MCR611377S MCR611382S MCR611383S MCR611384S MCR611385S MCR611387S MCR611388S MCR611390S MCR611391S MCR611409S MCR611413S MCR611416S MCR611417S MCR611422S MCR611423S MCR611424S MCR611427S MCR611428S MCR611434S MCR611436S MCR611437S MCR611439S MCR611440S MCR611441S MCR611445S MCR611446S MCR611447S MCR611449S MCR611450S MCR611452S MCR611455S MCR611457S…
FDA’s list runs to 291,654 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 291,654 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.