Baylis Medical Corp *: Medical Device Recall in 2015 - (Recall #: Z-0356-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 28, 2015

Date Posted: December 9, 2015

Recall Number: Z-0356-2016

Event ID: 72539

Reason for Recall:

Microcatheter may have circumferential defects (cracks) along its shaft.

Status: Terminated

Product Quantity: 433 units

Code Information:

CIFA161013, CIFA131113, CIFA271113, CIFA311213, CIFA210214, CIFA070314, CIFA270314, CIFA070514, CIFA210514, CIFA100614, CIFA240614, CIFB100714, CIFA100714, CIFA180814, CIFA080914, CIFA241014, CIFA221014, CIFA050115, CIFA210115, CIFA060215

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated