Reported Feb 14, 2018 · Terminated
Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI:…
Medtronic Neuromodulation
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
- Medtronic Ascenda(R) Intrathecal Catheter
- Models(a) 8780
- UDI
0064316920212200643169783027 (b) 8781
- UDI00643169202139 (c) 8784
- UDI00643169202153 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
- Lot codes and dates
- (a)
- Model 8780
183 of 183 codes
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
- N747546005 (b) Model 8781
N745579001N745579002N745579005N745579006
- N746858001 (c) Model 8784
N745557001N745557002N745557003N745557004N745557005
- Amount recalled
- 194 units
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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