Medtronic Recalls Ascenda Intrathecal Catheters Due to Retainer Ring Defect
Medtronic is recalling specific lots of Ascenda Intrathecal Catheters and Revision Kits because a retainer ring component may not meet specifications, risking catheter disconnection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (unintentional disconnection of an implanted medical device) where specific injury reports are not detailed in the provided text, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Medtronic Neuromodulation is removing specific lots of the Ascenda Intrathecal Catheters (models 8780 and 8781) and the Ascenda Intrathecal Catheter Pump Segment Revision Kit (model 8784) from the market. These devices are components of an implantable infusion system used to store and deliver parenteral drugs to the intrathecal space, typically used with the SynchroMed drug infusion pump.
The recall is being conducted because a single component of the catheter, the retainer ring, is not meeting specification criteria. This defect creates a possibility of unintentional disconnection of the catheter from the pump, or difficulty in disconnecting the device. The affected units were distributed worldwide, including nationwide in the United States and in various countries across Europe, the Middle East, South America, and Africa.
Patients with these implanted devices should contact their healthcare provider or Medtronic for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- 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 implan
- Manufacturer
- Medtronic Neuromodulation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- N464200
- N464206
- N464254
- N464257
- N464258
- N464262
- N464263
- N464264
- N464271
- N464693
- N464703
- N464708
- N464725
- N464727
- N464730
- N464734
- N464736
- N464738
- N464742
- N464746
Distribution
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