Recall Z-0955-2020— Medtronic Inc.
Class I · Ongoing
Class I FDA medical device recall by Medtronic Inc., initiated 2019-11-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only. Reason: 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..
- Recalling firm
- Medtronic Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2019-11-21
- Firm location
- Northridge, CA, United States
Product description
Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.