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

Recall Z-1668-2013 — Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.

U.S. FDA — Device Enforcement · United States · 2013-06-07 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1668-2013
Date of alert
2013-06-07
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Medtronic MiniMed
Product category
device
Product type
Devices
Reported risk: Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of Medtronic Paradigm infusion sets. Under certain conditions, the infusion set may malfunction and deliver an incorrect volume of insulin.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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.

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