Azure XT SR MRI
Medical device recall Z-2509-2020. 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
- 31736 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 XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
31736 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
a) W1SR01, serial numbers: RNA200005H RNA200007H RNA200011H RNA200013H RNA200016H RNA200017H RNA200020H RNA200021H RNA200022H RNA200024H RNA200025H RNA200026H RNA200028H RNA200029H RNA200089H RNA200090H RNA200091H RNA200092H RNA200093H…
Every code shown here, 1,996 characters
a) W1SR01, serial numbers: RNA200005H RNA200007H RNA200011H RNA200013H RNA200016H RNA200017H RNA200020H RNA200021H RNA200022H RNA200024H RNA200025H RNA200026H RNA200028H RNA200029H RNA200089H RNA200090H RNA200091H RNA200092H RNA200093H RNA200094H RNA200095H RNA200096H RNA200098H RNA200100H RNA200102H RNA200103H RNA200104H RNA200105H RNA200106H RNA200107H RNA200108H RNA200109H RNA200110H RNA200111H RNA200112H RNA200113H RNA200114H RNA200115H RNA200116H RNA200118H RNA200119H RNA200120H RNA200121H RNA200122H RNA200123H RNA200125H RNA200126H RNA200127H RNA200128H RNA200130H RNA200131H RNA200132H RNA200133H RNA200134H RNA200135H RNA200136H RNA200139H RNA200140H RNA200141H RNA200142H RNA200144H RNA200145H RNA200146H RNA200147H RNA200148H RNA200149H RNA200150H RNA200151H RNA200152H RNA200154H RNA200155H RNA200157H RNA200158H RNA200160H RNA200161H RNA200162H RNA200163H RNA200164H RNA200165H RNA200169H RNA200170H RNA200171H RNA200172H RNA200173H RNA200174H RNA200176H RNA200177H RNA200178H RNA200179H RNA200180H RNA200181H RNA200182H RNA200183H RNA200184H RNA200186H RNA200187H RNA200188H RNA200189H RNA200190H RNA200191H RNA200192H RNA200193H RNA200194H RNA200195H RNA200196H RNA200197H RNA200198H RNA200199H RNA200200H RNA200202H RNA200203H RNA200204H RNA200205H RNA200207H RNA200209H RNA200210H RNA200211H RNA200212H RNA200214H RNA200215H RNA200216H RNA200219H RNA200220H RNA200221H RNA200223H RNA200224H RNA200225H RNA200226H RNA200227H RNA200228H RNA200229H RNA200231H RNA200234H RNA200235H RNA200236H RNA200238H RNA200239H RNA200240H RNA200241H RNA200242H RNA200244H RNA200245H RNA200246H RNA200247H RNA200248H RNA200250H RNA200251H RNA200252H RNA200255H RNA200256H RNA200257H RNA200258H RNA200260H RNA200261H RNA200263H RNA200265H RNA200266H RNA200267H RNA200269H RNA200270H RNA200271H RNA200272H RNA200273H RNA200274H RNA200275H RNA200276H RNA200277H RNA200278H RNA200279H RNA200280H RNA200282H RNA200283H RNA200284H RNA200285H RNA200286H RNA200287H RNA200288H RNA200289H RNA200291H…
FDA’s list runs to 378,183 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 378,183 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.