Recall Z-0537-2018— Medtronic Neuromodulation
Class III · Terminated
Class III FDA medical device recall by Medtronic Neuromodulation, initiated 2017-09-21, terminated 2020-03-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2017-09-21
- Terminated
- 2020-03-20
- Firm location
- Minneapolis, MN, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.