—#178300

Product

Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, and MMT-1752 *Not for US Distribution

FDA product code: OZP — Automated Insulin Dosing Device System, Single Hormonal Control
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: All Serial Numbers ( excluding devices with black retainer rings) ***NOT DISTRIBUTED WITHIN THE US***

Why it was recalled

There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.

Root cause (FDA determination)

Device Design

Action the firm took

On November 21, 2019, Medtronic initiated a recall of MiniMed 600 series insulin pumps with a clear retainer ring design. On October 5, 2021, the firm expanded the recall and issued an "Urgent Field Safety Notification" to all patients and health care providers. The updated notification informs consignees that Medtronic will proactively replace all MiniMed 600 series insulin pumps that have a clear retainer ring design with an equivalent pump that has the updated black retainer ring design. Pumps will be replaced at no charge over the coming months even if the retainer ring is not damaged and regardless of the warranty status of the pump. In addition to providing consignees with this updated recall strategy, the firm asked consignees to take the following actions: ACTIONS REQUIRED BY YOU: 1. Complete and return the attached Confirmation Form to acknowledge that you have reviewed and understood this notification. 2. Medtronic is requesting patients visit [www.medtronicdiabetes.com/PumpRing] and complete the form online, or call us at 1-877-585-0166 to indicate their decision to receive a replacement pump at no charge. Replacement pumps will become available in the coming months and patients will be notified when their pump is ready to ship. Please assist patients in making replacement decision considering the safety risk associated with the retainer ring issue. For additional recall details, please view the following link: https://www.medtronicdiabetes.com/customer-support/product-and-service-updates/notice15-letter

Recalling firm

Firm: Medtronic Inc.
Address: 18000 Devonshire St, Northridge, California 91325-1219

Distribution

Distribution pattern: US:AK,AL,AR,AZ,BM,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY OUS: France, Germany, UK, Italy, Netherlands, Spain, Sweden, Israel, Norway, Austria, Belgium, Denmark, Czech Republic, Finland, Switzerland, Slovakia, Ireland, Poland, S. Africa, Greece, Hungary, Saudi Arabia, United Arab Emira, New Zealand, Australia, Japan, Mexico, Colombia, Brazil, S. East Asia, Korea, Canada,

Timeline

Recall initiated: 2019-11-21
Posted by FDA: 2020-02-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178300. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.