ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular.
FDA Recall Z-0356-2016 · Posted 2015-12-01
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Recalling FirmBaylis Medical Corp *
Recall StatusTerminated
Product CodeDQX
Date Initiated2015-10-28
Date Terminated2016-11-17
Product Quantity433 units
Reason for Recall
Microcatheter may have circumferential defects (cracks) along its shaft.
Firm Action
Recall notification letter was sent to affected consignees on 10/28/2015 via courier. The letter contained a fax-back form to be completed by the consignee and sent to the quality department of the recalling firm.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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