Azure S SR MRI
Medical device recall Z-2510-2020. 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
- 11953 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?
Azure S SR MRI, Model Number W3SR01
11953 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
serial numbers: RNI200028H RNI200029H RNI200031H RNI200033H RNI200034H RNI200037H RNI200038H RNI200039H RNI200041H RNI200042H RNI200043H RNI200044H RNI200045H RNI200046H RNI200048H RNI200050H RNI200051H RNI200053H RNI200054H RNI200055H…
Every code shown here, 1,996 characters
serial numbers: RNI200028H RNI200029H RNI200031H RNI200033H RNI200034H RNI200037H RNI200038H RNI200039H RNI200041H RNI200042H RNI200043H RNI200044H RNI200045H RNI200046H RNI200048H RNI200050H RNI200051H RNI200053H RNI200054H RNI200055H RNI200057H RNI200058H RNI200059H RNI200061H RNI200063H RNI200064H RNI200065H RNI200066H RNI200067H RNI200069H RNI200071H RNI200072H RNI200076H RNI200077H RNI200078H RNI200079H RNI200080H RNI200081H RNI200082H RNI200083H RNI200084H RNI200085H RNI200086H RNI200087H RNI200088H RNI200089H RNI200090H RNI200091H RNI200094H RNI200095H RNI200096H RNI200097H RNI200098H RNI200099H RNI200100H RNI200101H RNI200102H RNI200103H RNI200104H RNI200105H RNI200106H RNI200107H RNI200108H RNI200109H RNI200111H RNI200112H RNI200113H RNI200115H RNI200118H RNI200119H RNI200121H RNI200122H RNI200123H RNI200124H RNI200125H RNI200126H RNI200127H RNI200128H RNI200130H RNI200132H RNI200134H RNI200135H RNI200137H RNI200138H RNI200139H RNI200140H RNI200141H RNI200142H RNI200144H RNI200146H RNI200147H RNI200148H RNI200149H RNI200150H RNI200151H RNI200152H RNI200155H RNI200156H RNI200157H RNI200158H RNI200159H RNI200160H RNI200161H RNI200162H RNI200163H RNI200164H RNI200166H RNI200167H RNI200168H RNI200169H RNI200170H RNI200171H RNI200172H RNI200173H RNI200174H RNI200175H RNI200180H RNI200181H RNI200182H RNI200183H RNI200184H RNI200186H RNI200187H RNI200188H RNI200195H RNI200202H RNI200203H RNI200116H RNI200143H RNI200177H RNI200178H RNI200191H RNI200192H RNI200193H RNI200194H RNI200196H RNI200197H RNI200198H RNI200199H RNI200200H RNI200201H RNI200060H RNI200092H RNI200210H RNI200211H RNI200214H RNI200236H RNI200241H RNI200243H RNI200270H RNI200273H RNI200280H RNI200282H RNI200300H RNI200302H RNI200303H RNI200304H RNI200305H RNI200312H RNI200313H RNI200315H RNI200327H RNI200330H RNI200335H RNI200347H RNI200359H RNI200371H RNI200208H RNI200209H RNI200219H RNI200230H RNI200232H RNI200240H RNI200268H RNI200284H RNI200287H RNI200296H RNI200326H RNI200338H RNI200363H…
FDA’s list runs to 140,739 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 140,739 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.