Reported Jul 15, 2020 · Ongoing
Azure S DR MRI, Model Number W3DR01
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
- Azure S DR MRI, Model Number W3DR01
- Lot codes and dates
- serial numbersRNJ
2,715 of 2,715 codes
RNJ200027HRNJ200025HRNJ200023HRNJ200022HRNJ200020HRNJ200018HRNJ200017HRNJ200015HRNJ200014HRNJ200011HRNJ200009HRNJ200008HRNJ200007HRNJ200006HRNJ200005HRNJ200004HRNJ200086HRNJ200085HRNJ200084HRNJ200083HRNJ200082HRNJ200081HRNJ200080HRNJ200078HRNJ200077HRNJ200076HRNJ200075HRNJ200074HRNJ200073HRNJ200072HRNJ200071HRNJ200070HRNJ200069HRNJ200068HRNJ200067HRNJ200066HRNJ200064HRNJ200063HRNJ200062HRNJ200061HRNJ200060HRNJ200059HRNJ200058HRNJ200057HRNJ200056HRNJ200055HRNJ200054HRNJ200052HRNJ200051HRNJ200050HRNJ200049HRNJ200048HRNJ200047HRNJ200046HRNJ200045HRNJ200043HRNJ200041HRNJ200040HRNJ200039HRNJ200038H
- serial numbers
- Amount recalled
- 49513 devices
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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