Reported Aug 20, 2014 · Terminated
Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision…
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784. The Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and an Ascenda Intrathecal Catheter.
- Lot codes and dates
- Serial
- Numbers are in the following format"N" + 9 digits (e.g. N12345001. Product beginning with the following
- letter/number combinations are affected
310 of 310 codes
N464184N464200N464206N464254N464257N464258N464262N464263N464264N464271N464693N464703N464708N464725N464727N464730N464734N464736N464738N464742N464746N464750N464752N464841N464924N464930N464995N464995N465020N465038N465063N465065N465073N465082N465088N465091N465094N465111N465125N465129N465131N465136N465138N465144N465145N465146N465148N465150N466065N466067N466067N466068N466069N466071N466072N466075N466134N466167N466177N466196
- Amount recalled
- 1200 (551 US, 649 OUS)
Where it was sold
Why it was recalled
Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which are used with the implantable SynchroMed drug infusion pump. This recall is being conducted due to a single component of the catheter, the retainer ring, not meeting specification criteria. There is a possibility of unintentional disconnection of the catheter from the pump, or difficulty in disconne
This product could cause temporary or reversible health problems — stop using it.
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