RecallDepth

Paradigm Model 511 and 512 Insulin Infusion Pumps

Company
Medtronic Minimed
Recall Initiated
August 29, 2003
Posted
November 27, 2003
Terminated
September 2, 2005
Recall Number
Z-0168-04
Quantity
Approximately 61,000 patients
Firm Location
Northridge, CA

Reason for Recall

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

Distribution

Nationwide and Canada

Lot / Code Info

Codes are irrelevant

Root Cause

Other

Action Taken

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.

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