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