Reported Jul 15, 2020 · Ongoing
Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
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?
- Solara CRT-P MRI
- Model Numbers
a) W1TR03b) W1TR06c) W4TR03d) W4TR06
- Lot codes and dates
- a) W1TR03
- serial numbersb) W1TR06
1,982 of 1,982 codes
RNS200027HRNS200037HRNS200043HRNS200044HRNS200045HRNS200052HRNS200059HRNS200063HRNS200068HRNS200076HRNS200077HRNS200079HRNS200081HRNS200088HRNS200089HRNS200090HRNS200094HRNS200098HRNS200100HRNS200005HRNS200007HRNS200016HRNS200020HRNS200022HRNS200025HRNS200026HRNS200028HRNS200030HRNS200032HRNS200033HRNS200034HRNS200038HRNS200042HRNS200050HRNS200051HRNS200054HRNS200060HRNS200061HRNS200064HRNS200065HRNS200067HRNS200071HRNS200072HRNS200074HRNS200080HRNS200082HRNS200084HRNS200085HRNS200086HRNS200087HRNS200091HRNS200093HRNS200099HRNS200101HRNS200053HRNS200104HRNS200109HRNS200111HRNS200116HRNS200118H
- serial numbers
730 of 730 codes
RNY600012SRNY600014SRNY600015SRNY600016SRNY600020SRNY600025SRNY600028SRNY600032SRNY600033SRNY600036SRNY600037SRNY600038SRNY600042SRNY600043SRNY600045SRNY600047SRNY600049SRNY600052SRNY600054SRNY600055SRNY600056SRNY600058SRNY600059SRNY600062SRNY600063SRNY600064SRNY600065SRNY600066SRNY600067SRNY600068SRNY600069SRNY600070SRNY600071SRNY600072SRNY600074SRNY600075SRNY600076SRNY600078SRNY600079SRNY600081SRNY600082SRNY600083SRNY600084SRNY600085SRNY600086SRNY600095SRNY600099SRNY600100SRNY600104SRNY600105SRNY600106SRNY600107SRNY600110SRNY600111SRNY600115SRNY600118SRNY600119SRNY600121SRNY600122SRNY600127S
- Amount recalled
- 16667 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.
Want the full recall guide?
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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