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Recall Observatory FDA recall evidence

Device product

NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0863-2013

January 11, 2013

Class II

Product summary

Firm
Codman & Shurtleff, Inc.
Event
Event 64158
Status
Terminated
Classification
Class II
Quantity
64 units
Official record key
device-enforcement:Z-0863-2013

Official wording

Reason: Sterility of device may be compromised due to lack of package integrity

Code information: All unexpired lots

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sterility of device may be compromised due to lack of package integrity