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Open, Classified

Azure S DR MRI, Model Number W3DR01

FDA Recall Z-2508-2020 · Posted 2020-07-10

Recalling FirmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Recall StatusOpen, Classified
Product CodeNVZ
Date Initiated2020-06-04
Product Quantity49513 devices

Reason for Recall

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.

Firm Action

The firm initiated their medical device correction on 06/04/2020 by letter. The letter explained the problem and informed the consignee of the available software update (version 3.2.01) along with download instructions.

Root Cause

Software design

Distribution Pattern

worldwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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