Z-1442-2015Class II

ProTrack Microcatheter

Name: Z-1442-2015 ProTrack Microcatheter
Creator: Baylis Medical Corp *
Published: 2015-03-30
License: https://open.fda.gov/license/

Baylis Medical Co., Inc. / initiated 2015-03-30 / Terminated / root cause: manufacturing process

FDA source

Baylis Medical Corp * began a recall of 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... on 2015-03-30. FDA classified it as Class II and gives the reason as "Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects 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-1442-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-30
Posted: 2015-04-13
Terminated: 2016-11-17
Recalling firm: Baylis Medical Co., Inc.
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.
Product code: DQX Wire, Guide, Catheter
Reason for recall: Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects along its shaft.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A recall notification, marked "URGENT" will be sent by Baylis Medical via overnight courier to all customers affected by the recall with a fax-back form. The form is to be faxed back to Baylis Medical confirming receipt of the recall notice. As per instructions on the fax-back form, affected devices are requested to be returned. Baylis Medical will replace the returned affacted catheters with a new catheter.
Quantity in commerce: 58 units
Distribution: US Nationwide Distribution - US Nationwide in the states of MO, MA, OH, CA, AR, MA, FL, GA, CO, TX, KY, NY, MI, WI, OR
Product codes and lots: Lots CIFA180814 and CIFA080914

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1442-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1442-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-22	2015-04-13

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)