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Terminated

Paradigm Model 511 and 512 Insulin Infusion Pumps

FDA Recall Z-0168-04 · Posted 2003-11-27

Recalling FirmMedtronic MiniMed
Recall StatusTerminated
Product CodeLZG
Date Initiated2003-08-29
Date Terminated2005-09-02
Product QuantityApproximately 61,000 patients

Reason for Recall

Water ingresses into the device when in prolonged contact with water causing device to malfunction.

Firm Action

The firm sent notifications to all pump users of record, all distributors and all certified pump trainers indications that the pumps should not be immersed in water. Canadian users were contacted by Medtronic Canada.

Root Cause

Other

Distribution Pattern

Nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K001829MINIMED PARADIGM INSULIN PUMP, MODEL 511Minimed, Inc. · 2000-08-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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