Product Wiki · Recalls · U.S. FDA — Device Enforcement

Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UDI: 00643169202153 The Ascenda Intrathecal Catheter kits (models 8780, 8781 and 8784) contain parts of an infusion system that delivers drugs to the intr — recall Z-0537-2018

U.S. FDA — Device Enforcement · United States · 2017-09-21 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0537-2018
Date of alert: 2017-09-21
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Medtronic Neuromodulation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00643169202122

Reported risk: There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at the proximal end where the catheter connects to the drug infusion pump.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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