FDASeptember 21, 2017device
Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UDI: 00643169202153 The Ascenda Intrathecal Catheter kits (models 8780, 8781 and 8784) contain parts of an infusion system that delivers drugs to the intratheca...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at the proximal end where the catheter connects to the drug infusion pump.
What to do
FDA enforcement status: Terminated
Brands named
medtronic neuromodulationmedtronic
UPCs
00643169202122006431697830270064316920213900643169202153
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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