Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and C

FDA device recall Z-2179-2014 · posted 2014-08-10 · Terminated

Recall details

Recalling firm

Medtronic MiniMed Inc.

Reason for recall

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.

Action taken

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, ext. 21090, 8am-6pm, CST.

Root cause

Device Design

Status

Terminated

Product code

MDS

Quantity affected

86 units

Distribution

Worldwide:Distribution - US Nationwide and the countries of Croatia, Denmark, Finland, Germany, Netherlands, Norway, Sweden, Switzerland.

Date initiated

2014-07-21

Date posted

2014-08-10

Date terminated

2014-10-08

Location

Northridge, CA