Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-71
FDA device recall Z-2544-2014 · posted 2014-08-22 · Terminated
Recall details
- Recalling firm
- Medtronic MiniMed Inc.
- Reason for recall
- Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally programmed the pump to deliver the maximum bolus amount.
- Action taken
- The firm, Medtronic, sent an "IMPORTANT MEDICAL DEVICE SAFETY INFORMATION" letter dated March 13, 2014 to its customers. The letter described the product, problem and actions to be taken. The letter informs the customers that because accidental button pressing errors may occur it is important that customers always confirm the insulin dose flashing on the display is correct before pressing ACT to start delivery. The letter informs the customers of what safety settings will minimize the risk of an accidental programming error and what actions to be taken. Should you have any questions about this letter or concerns with your keypad, please do not hesitate to contact the 24 hour helpline at (866) 222-7304 for a replacement.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OYC
- Quantity affected
- 559,374 units total (444,374 units in US)
- Distribution
- Worldwide Distribution-Nationwide in US
- Date initiated
- 2014-03-13
- Date posted
- 2014-08-22
- Date terminated
- 2015-04-07
- Location
- Northridge, CA
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