Recall Z-2603-2017 ยท OZO Automated Insulin Dosing , Threshold Suspend
Medtronic Inc.
MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.
| Date | May 8, 2017 |
| Status | Terminated |
| Reason | Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive. |
| Root cause | Device Design |
| 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 at1-888-2 |
| Quantity | 65,959 pumps |
| Distribution | US and OUS Angola Aruba Australia/NZ Austria Bahamas Bahrain Bangladesh Belgium Bolivia Botswana Bulgaria Cayman Islands Colombia Costa Rica Croatia Cyprus Czech Republic Denmark Dominican Republic El Salvador Estonia Faroe Islands Finland France Germany Greece Guadeloupe Guatemala Hong Kong Hungar |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.