High FDA (Devices)·Z-0356-2016·Announced 2015-12-09

Baylis ProTrack Microcatheter Recalled for Circumferential Shaft Cracks

Baylis Medical Corp is recalling 433 ProTrack Microcatheters nationwide due to circumferential cracks along the shaft.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect (cracks) that poses a risk of harm during use, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Baylis Medical Corp is recalling 433 units of the ProTrack Microcatheter, models CIC38-145 and CIC35-145. These sterile, single-use devices are intended for use as standard infusion wires or exchange guides in cardiovascular procedures. The recall is due to the potential presence of circumferential defects, specifically cracks, along the catheter shaft.

The affected products were distributed nationwide. The recall includes units with specific lot codes, including CIFA161013, CIFA131113, and others listed in the agency record. The source text does not report any specific illnesses or injuries associated with this defect.

Healthcare providers and consumers should stop using the affected ProTrack Microcatheters immediately. Users should check their inventory for the specific model numbers and lot codes listed in the recall notice. For further information or to arrange a return, contact Baylis Medical Corp.

The recalled product

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.
Manufacturer: Baylis Medical Corp *
Category: Medical Device — Cardiovascular Catheter
Hazard: structural-defect
cracking
Affected units: 433

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

Same manufacturer · Baylis Medical Corp *

See all →

Moderate
Baylis Medical Recalls NRG Transseptal Needles Due to Packaging Defect
FDA (Devices) · 2016-11-16
High
Baylis Medical Recalls ProTrack Microcatheter Due to Circumferential Shaft Defects
FDA (Devices) · 2015-04-22
High
Baylis Medical Recalls TorFlex Transseptal Guiding Sheath Kits
FDA (Devices) · 2013-11-13

Same hazard · structural defect