Terminated

MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.

FDA Recall Z-2603-2017 · Posted None

Recalling FirmMedtronic Inc.

Recall StatusTerminated

Product CodeOZO

Date Initiated2017-05-08

Date Terminated2021-01-20

Product Quantity65,959 pumps

Reason for Recall

Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive.

Firm Action

On May 19, 2017, an Urgent Field Safety Notification letter will be sent to customers to inform them that Medtronic MiniMed is recalling MiniMed 600 series insulin pumps because they may be temporarily stuck, and the keypad becomes unresponsive. Customers are instructed how the key becomes temporarily unresponsive, how to notice if this happens, and what to do if this happens to their pumps. Customers with questions or concerns are instructed to find an FAQ and a copy of the letter at http://www.medtronicdiabetes.com/notice6. Customers can also reach the Medtronic 24-Hour HelpLine at1-888-204-7616.

Root Cause

Device Design

Distribution Pattern

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Official Source

View FDA Recall →

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