Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68295

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 02, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medtronic Neuromodulation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1723-2014
Recall number
Z-1723-2014
Initiated
May 02, 2014
Classification
Class II
Status
Terminated
Recalling firm
Medtronic Neuromodulation
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Release of Material/Component prior to receiving test results

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.

Code information

N457062003

Distribution pattern

Distributed in the state of CT.