FDAFDA · Food and drugs·Recall number Z-0955-2020
Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only
Published February 19, 2020 · Recall initiated: November 21, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Inc.
- Distributor
- 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,
- Lot
- All Serial Numbers ( excluding devices with black retainer rings)
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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