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Terminated

Medtronic MiniMed Paradigm Model 712

FDA Recall Z-0010-05 · Posted None

Recalling FirmMedtronic MiniMed
Recall StatusTerminated
Product CodeLZG
Date Initiated2004-09-14
Date Terminated2005-03-03
Product Quantity10,600

Reason for Recall

Several complaints of pumps exhibiting A47 alarms were received. Investigation revealed the alarms occurred when the pump attempted to display text that exceeded the maximum display length of the pump screen. The investigation revealed this only occurs when the pump is programmed to display information in Spanish.

Root Cause

Other

Distribution Pattern

Nationwide & Spain

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030531MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METERMinimed, Inc. · 2003-06-17

Official Source

View FDA Recall →

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

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