CLASS II Device recall · Reported 9 Dec 2015 · FDA Enforcement Report

ProTrack Microcatheter recalled by Baylis Medical Corp *

Baylis Medical Corp * is recalling ProTrack Microcatheter, distributed nationwide in the US. The recall was initiated on 28 Oct 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCIFA161013, CIFA131113, CIFA271113, CIFA311213, CIFA210214, CIFA070314, CIFA270314, CIFA070514, CIFA210514, CIFA100614, CIFA240614, CIFB100714, CIFA100714, CIFA180814, CIFA080914, CIFA241014, CIFA221014, CIFA050115, CIFA210115, CIFA060215

Quantity recalled433 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0356-2016
FDA event ID: 72539
Recalling firm: Baylis Medical Corp *, Montreal
Classification: Class II
Status: Terminated
Recall initiated: 28 Oct 2015
FDA classified: 1 Dec 2015
Reported: 9 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

28 Oct 2015	Recall initiated by company
1 Dec 2015	Classified by FDA	+34 days
9 Dec 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Is ProTrack Microcatheter recalled?

Yes. Baylis Medical Corp * recalled ProTrack Microcatheter on 28 Oct 2015. The recall is Class II and its status is Terminated. Recall number Z-0356-2016.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Baylis Medical Corp *

All 4

Reported	Class	Recall	Company	Reason	Where
16 Nov 2016Device	CLASS II	NRG Transseptal Needle and NRG RF Transseptal Kit recalled	Baylis Medical Corp *	Packaging Defects
22 Apr 2015Device	CLASS II	ProTrack Microcatheter recalled by Baylis Medical Corp *	Baylis Medical Corp *	Sterility	Nationwide
13 Nov 2013Device	CLASS I	Baylis Medical TorFlex Transseptal Guiding Sheath recalled	Baylis Medical Corp *	Particulate Matter	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide