Medtronic Ascenda Intrathecal Catheter design update to prevent occlusion
Medtronic is updating the design of its Ascenda Intrathecal Catheter (Models 8780, 8781, 8784) to reduce potential tissue growth into the catheter connector that may cause occlusion. Approximately 111,762 units were distributed worldwide.
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: This is a FDA Class II recall for a risk-of-harm medical device (intrathecal catheter) with a serious potential hazard (catheter occlusion). However, the source does not report any actual illnesses or injuries, and the hazard is theoretical, placing this at score 3 per the rubric criteria.
Plain-English summary
Medtronic Neuromodulation has issued a design update for its Ascenda Intrathecal Catheter, affecting three models: 8780 (114 cm), 8781 (140 cm), and 8784 (catheter pump revision kit). Approximately 111,762 units have been distributed worldwide, including throughout the United States and numerous international countries.
The design update is intended to reduce the potential for tissue growth into the catheter connector, which may lead to catheter occlusion. Catheter occlusion could impair the proper delivery of medication or treatment through the device.
The affected catheters were distributed to healthcare facilities and patients worldwide. Patients and healthcare providers using affected units should contact Medtronic Neuromodulation regarding the design update. Patients should not discontinue use without consulting their healthcare provider.
The recalled product
- Product
- Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- tissue-growth
- device-occlusion
- device-malfunction
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)
- a) 8780: 1) UDI/DI 00643169202122
- Lot/Serial Numbers: N690838001
- N690838004
- N690838005
- N690839001
- N690839002
- N690839003
- N690839004
- N690839005
- N690839006
- N690840001
- N690840002
- N690840003
- N690840004
- N690840005
- N690840006
- N690841001
- N690841004
- N690841005
- N690842001
Distribution
Distributed nationwide across the United States.
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