FDAJune 21, 2023device
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not available for download.
What to do
FDA enforcement status: Ongoing
Brands named
medtronic neuromodulationmedtronic
UPCs
643169738058
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAOctopus Evolution Tissue Stabilizer, Model TS20002026-05-12
- FDAOctopus 4 Tissue Stabilizer, Model 294002026-05-12
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- FDABoston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm); REF: CSK-TC15, CSK Electrode, STAINLESS STEEL, 15 cm x 28 ga (0.36 mm); REF: CSK-TC15-3M, CSK Electrode, STA...2026-04-29
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