FDA Recall Terminated

MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.

Recall: Z-2602-2017 · Initiated May 8, 2017

Recall

Recall Number
Z-2602-2017
Event Number
77188
Firm
Medtronic Inc.
FEI Number
3003166194
Product Code
OZO
Status
Terminated
Root Cause
Device Design
Initiated
May 8, 2017
Terminated
January 20, 2021
Address
18000 Devonshire St, Northridge, CA, 91325-1219

Description

MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.

Reason

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

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.

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 Hungary Iceland India Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea Kuwait Latvia Lebanon Liechtenstein Lithuania Luxembourg Macedonia Malaysia Martinique Mauritius Morocco Namibia Nepal Netherlands New Caledonia Norway Oman Panama Paraguay Philippines Poland Portugal Qatar Reunion Romania San Marino Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Tanzania Thailand Trinidad and Tobago Turkey United Arab Emirates United Kingdom

Quantity

6,573 pumps