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Recall Observatory FDA recall evidence

Device product

ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.

Z-1442-2015

March 30, 2015

Class II

Product summary

Firm
Baylis Medical Corp *
Event
Event 70896
Status
Terminated
Classification
Class II
Quantity
58 units
Official record key
device-enforcement:Z-1442-2015

Official wording

Reason: Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects along its shaft.

Code information: Lots CIFA180814 and CIFA080914

Distribution pattern: US Nationwide Distribution - US Nationwide in the states of MO, MA, OH, CA, AR, MA, FL, GA, CO, TX, KY, NY, MI, WI, OR

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects along its shaft.