FDA (Devices) recall action 85816
The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.
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 p…
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medtronic is recalling 31,736 Azure XT SR MRI devices due to a rare communication issue that temporarily suspends certain device features.
Medtronic is recalling 37,360 Percepta CRT-P MRI devices due to a rare communication issue that may temporarily suspend certain device features.
Medtronic is recalling 17,750 Serena CRT-P MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.
Medtronic is recalling 266,252 Azure XT DR MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.
Medtronic is recalling 2,773 CareLink SmartSync Device Manager units worldwide because a rare communication error may temporarily suspend certain device features.
Medtronic is recalling 49,513 Azure S DR MRI devices because a rare communication issue may temporarily suspend certain device features.
Medtronic is recalling 11,953 Azure S SR MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.
Medtronic is recalling 1,025 Patient Connectors because a rare communication error may temporarily suspend device features. The issue is unlikely to cause clinical impact and features restore automatically.
Medtronic is recalling 16,667 Solara CRT-P MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.