Z-0955-2020Class I

Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and...

Name: Z-0955-2020 Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and...
Creator: Medtronic Inc.
Published: 2019-11-21
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2019-11-21 / Open, Classified / root cause: design

FDA source

Medtronic Inc. began a recall of Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only on 2019-11-21. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0955-2020
Classification: Class I
Status: Open, Classified
Initiated: 2019-11-21
Posted: 2020-02-07
Recalling firm: Medtronic, Inc.
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
Product code: OZO Automated Insulin Dosing , Threshold Suspend
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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
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,
Product codes and lots: All Serial Numbers ( excluding devices with black retainer rings)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0955-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0955-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-07
Z-0956-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-07
Z-0957-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-07
Z-0958-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-07

Product code OZO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)