Severity
Moderate
FDA Devices recall · Reported June 11, 2014
Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.
Medtronic Neuromodulation recalled Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 878… - a moderate-severity action.
Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 878… was recalled by Medtronic Neuromodulation in June 11, 2014. Reason: Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.. Check the official notice for the remedy. Verify recall #Z-1723-2014 with the FDA Devices before acting.
The recall
Medtronic Neuromodulation issued this moderate-severity FDA Devices recall-Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits..
Sourced from official FDA Devices enforcement records. Verify recall #Z-1723-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1723-2014) was formally reported on June 11, 2014, with the manufacturer initiating the action on May 2, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Neuromodulation is listed as the recalling firm, operating out of Minneapolis, MN. Federal records list the affected scope as 1.
The documented reason for this recall is: Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits. Distribution data in the federal record shows the product reached: Distributed in the state of CT.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
1
Related Recalls
6
3 from same agency
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 Medtronic pump and a Model 8780 Ascenda Intrathecal Catheter.
Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1723-2014 |
| Date reported | June 11, 2014 |
| Date initiated | May 2, 2014 |
| Recalling firm | Medtronic Neuromodulation |
| Firm location | Minneapolis, MN |
| Affected scope | 1 |
| Distribution | Distributed in the state of CT. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 11, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.