FDA Device Recall Z-0957-2020

Medtronic Inc. · Northridge, CA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MMT-1750 *Not Distributed within the US

Lot / serial / GTIN: All Serial Numbers ( excluding devices with black retainer rings) ***NOT DISTRIBUTED WITHIN THE US***

Reason for recall

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.

Recall record

Recall number: Z-0957-2020
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: 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,
Recall initiated: 2019-11-21
Classified by FDA Center: 2020-02-07
FDA published: 2020-02-19
Recalling firm: Medtronic Inc.
Firm location: Northridge, CA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All device recalls