Class II — Medtronic MiniMed Inc.
| Recalling firm | Medtronic |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue that has the potential to compromise the water resistance of the affected Guardian monitors. |
| Product | Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combination with the Minilink transmitter and Sof-sensor glucose sensor for continuous monitoring of subcutaneous glucose concentration. The information provided by these devices is intended for use in identifying potential episodes of high or low blood glucose. The information provided is not intended to be used directly for making therapy adjustment but rather to assist the user in determining that an additional fingerstic… |
| Quantity | 86 units |
| Distribution | Worldwide:Distribution - US Nationwide and the countries of Croatia, Denmark, Finland, Germany, Netherlands, Norway, Sweden, Switzerland. |
| Initiated | 2014-07-21 |
| Classified | 2014-08-09 |
| Terminated | 2014-10-08 |
| Recall number | Z-2179-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medtronic MiniMed Inc. (Z-2179-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68888/
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