Reported Jul 24, 2024 · Ongoing

Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)

Medtronic Neuromodulation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568

Is this the product you have?

  • Medtronic Ascenda Intrathecal Catheter
  • Models
    • a) 8780 (114 cm)
    • b) 8781 (140 cm)
    • c) 8784 (catheter pump revision kit)
Lot codes and dates
  • a) 87801) UDI/DI 00643169202122
  • Lot/Serial Numbers

    2,712 of 2,712 codes

    • N690838001
    • N690838004
    • N690838005
    • N690839001
    • N690839002
    • N690839003
    • N690839004
    • N690839005
    • N690839006
    • N690840001
    • N690840002
    • N690840003
    • N690840004
    • N690840005
    • N690840006
    • N690841001
    • N690841004
    • N690841005
    • N690842001
    • N690842003
    • N690842004
    • N690842005
    • N690843001
    • N690843003
    • N690843004
    • N690843005
    • N690915002
    • N690915003
    • N690915005
    • N690916001
    • N690916002
    • N690916003
    • N690916005
    • N690916006
    • N690917002
    • N690917003
    • N690918001
    • N690918002
    • N690918003
    • N690918004
    • N690918005
    • N690918006
    • N690919001
    • N690919002
    • N690919003
    • N690919005
    • N690919006
    • N690920001
    • N690920004
    • N690920005
    • N691336003
    • N691336004
    • N691336005
    • N691338001
    • N691338003
    • N691338004
    • N691338005
    • N691338006
    • N691456001
    • N691456002
Amount recalled
111762 units

Where it was sold

  • Nationwide

Why it was recalled

Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:40 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.