Medtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
Medtronic is recalling 20 MiniMed Flex insulin pumps that failed or lacked verification test results, posing risks of inaccurate insulin delivery and device malfunctions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as Class II, and the source identifies hazards including inaccurate insulin delivery and reduced occlusion detection, which are serious adverse health consequences for insulin-dependent patients. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medtronic MiniMed, Inc. is recalling 20 MiniMed Flex insulin pumps (models MMT-8062 and MMT-8072) that were released with missing or failed verification test results in one or more of nine functional tests. The affected pumps were distributed nationwide in 17 states, including Arizona, Colorado, Florida, and Texas.
The unverified or failed pumps may have issues such as inoperability at setup, lack of moisture protection, slow battery charging, disconnection from continuous glucose monitors or the mobile app, reduced ability to detect occlusion events, compromised alarm audio, and inaccurate insulin delivery. These defects could compromise the management of diabetes mellitus for users relying on the device.
Users should check their pump serial numbers against the list provided by Medtronic. If a pump is affected, users should stop using it and contact Medtronic for instructions on replacement or repair. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an alternate controller enabled (ACE) pump intended for the subcutaneous delivery of insulin, at set and variable rates, for…
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Insulin Pump
- Affected units
- 25
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- MMT-8072 Lot Code: Serial numbers: FB00015839
- FB00016511
- FB00014455
- FB00011553
- FB00015700
- FB00011357
- FB00019307
- FB00014766
- FB00014822
- FB00015828
- FB00018580
- FB00010465
- FB00014472
- FB00015793
- FB00015794
- FB00015796
- FB00015799
- FB00015801
- FB00015977
- FB00015162
Distribution
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