Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.

FDA device recall Z-2777-2015 · posted 2015-09-17 · Terminated

Recall details

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Management

Reason for recall

An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.

Action taken

Medtronic began hand delivering an Urgent Medical Device Correction letter on September 1, 2015, to all affected customers. The letter described the issue. Customers were advised to continue using the device, per the operator's manual, and if a system notice appears, they are to carefully read and follow the instructions in the screen of the console. Medtronic personnel will track contact with the customer via Customer Contact Record. Customers with qeustions were instructed to contact their Medtronic AF Solutions representative. For questions regarding this recall call 1-877-464-2796 Technical Services.

Root cause

Component design/selection

Status

Terminated

Product code

LPB

Quantity affected

103 units

Distribution

Worldwide Distribution - US (nationwide) and Internationally to Algeria, Australia, France, Germany, Greece, Iceland, Ireland, Israel, Italy, Lebanon, Malaysia, Martinique, Netherlands, Poland, Romani

Date initiated

2015-09-01

Date posted

2015-09-17

Date terminated

2016-04-08

Location

Saint Paul, MN