Medtronic Neuromodulation recalls Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 0064316…

Recall date

September 21, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0537-2018

FDA classification

Class III

Brand / firm

Medtronic Neuromodulation

Sold / distributed

Nationwide Distribution

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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 intrathecal space. The implanted system consists of an implantable infusion pump and an Ascenda catheter. The catheter connects to the pump at the catheter port and enters the intrathecal space.