Medtronic Ascenda Intrathecal Catheter Recalled for Endotoxin Contamination
Medtronic is recalling Model 8780 Ascenda Intrathecal Catheters because they may contain endotoxin levels exceeding USP limits.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a high-risk pathogen (endotoxin) in an implantable medical device where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Medtronic Neuromodulation is recalling the Model 8780 Ascenda Intrathecal Catheter. This implantable device is part of an infusion system used to store and deliver parenteral drugs to the intrathecal space. The recall was initiated because the company determined that an Ascenda catheter kit may have contained endotoxin in excess of United States Pharmacopeia (USP) limits.
The affected product was distributed in the state of Connecticut. The recall is classified as Class II by the U.S. Food and Drug Administration. No specific lot numbers, dates, or unit counts are provided in the source text.
Patients with implanted Medtronic Model 8780 Ascenda Intrathecal Catheters should contact their healthcare provider for guidance regarding the recall and potential next steps.
The recalled product
- Product
- Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 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…
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- Affected units
- 1
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 (1)
- N457062003
Distribution
Distributed in 1 state:
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