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Terminated

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

FDA Recall Z-2777-2015 · Posted 2015-09-17

Recalling FirmMedtronic Inc. Cardiac Rhythm Disease Management
Recall StatusTerminated
Product CodeLPB
Date Initiated2015-09-01
Date Terminated2016-04-08
Product Quantity103 units

Reason for Recall

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

Firm Action

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

Distribution Pattern

Worldwide Distribution - US (nationwide) and Internationally to Algeria, Australia, France, Germany, Greece, Iceland, Ireland, Israel, Italy, Lebanon, Malaysia, Martinique, Netherlands, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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