FDA Medical Device Recalls (openFDA)
Medtronic Inc.: Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)
- Recall number
- Z-0111-2018
- Recalling firm
- Medtronic Inc.
- Product
- Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)
- Status
- Open, Classified
- Initiated
- 2017-09-10
- Posted
- not on file
- Terminated
- not on file
- Reason
- Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
- Root cause
- Component design/selection
- Action
- The firm initiated its recall on 09/11/2017 by issuing a public notice, following with letters and emails. The firm also employed the use of Facebook and Twitter as well as posting on its website. The recall notice directs the customer to visit https://checklots.medtronicdiabetes.com for information on the lot numbers. Persons with additional questions may call Medtronic at 1.888.204.7616.
- Quantity
- 5,842 units
- Distribution
- Worldwide
- Lot, serial or model codes
- Lot Numbers: 6211649, 6207537
- 510(k) numbers
- ["K160651"]
- PMA numbers
- not on file
- Product code
- FPK
- Firm FEI
- 3003166194
- Firm city
- Northridge
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28