Recall Z-2179-2014 ยท MDS Sensor, Glucose, Invasive
Medtronic MiniMed Inc.
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 episod
| Date | Aug 10, 2014 (initiated Jul 21, 2014) |
| 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. |
| Root cause | Device Design |
| Action | Medical Device Recall letters dated July 21, 2014 andJuly 22, 2014 were sent to distributors, patients, and healthcare providers who purchased the Guardian REAL time monitors. The letters inform the customers of the problems identified and the actions to be taken. Distributors with questions are instructed to email rs.nrdlrinbox@medtronic.com. If healthcare professionals want to speak to Medtronic's medical officers then they are instructed to call (818) 576-4211, ext. 64511. Customers and healthcare professionals' patients are instructed to call Guardian Recall Hotline at (800) 646-4633, |
| Quantity | 86 units |
| Distribution | Worldwide:Distribution - US Nationwide and the countries of Croatia, Denmark, Finland, Germany, Netherlands, Norway, Sweden, Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.