Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06

FDA device recall Z-2513-2020 · posted 2020-07-10 · Open, Classified

Recall details

Recalling firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

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.

Action taken

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

Status

Open, Classified

Product code

NVZ

Quantity affected

16667 devices

Distribution

worldwide

Date initiated

2020-06-04

Date posted

2020-07-10

Location

Mounds View, MN