Z-0356-2016Class II

ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be...

Name: Z-0356-2016 ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be...
Creator: Baylis Medical Corp *
Published: 2015-10-28
License: https://open.fda.gov/license/

Baylis Medical Co., Inc. / initiated 2015-10-28 / Terminated / root cause: manufacturing process

FDA source

Baylis Medical Corp * began a recall of 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... on 2015-10-28. FDA classified it as Class II and gives the reason as "Microcatheter may have circumferential defects (cracks) along its shaft". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0356-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-28
Posted: 2015-12-01
Terminated: 2016-11-17
Recalling firm: Baylis Medical Co., Inc.
Product: 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 code: DQX Wire, Guide, Catheter
Reason for recall: Microcatheter may have circumferential defects (cracks) along its shaft.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 433 units
Distribution: Nationwide Distribution.
Product codes and lots: CIFA161013, CIFA131113, CIFA271113, CIFA311213, CIFA210214, CIFA070314, CIFA270314, CIFA070514, CIFA210514, CIFA100614, CIFA240614, CIFB100714, CIFA100714, CIFA180814, CIFA080914, CIFA241014, CIFA221014, CIFA050115, CIFA210115, CIFA060215

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0356-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0356-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-12-01

Product code DQX

K014075Class IIBmc Coaxial Injectable Catheter, Model Cic 38/145 and Cic 35/145Baylis Medical Co., Inc. / cleared 2002-03-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)