Food, drugs, devices › Baylis Medical Corp *
Device recall: ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as
FDA enforcement event 70896 is a device recall by Baylis Medical Corp * of Montreal, N/A, initiated 30 Mar 2015 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 17 Nov 2016. Initiation: voluntary: firm initiated. Baylis Medical Corp * has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Baylis Medical Corp *, Montreal, N/A, Canada.
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."
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 records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1442-2015 | 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. | 58 units | Class II | Terminated | 22 Apr 2015 |
Context
Other enforcement events for Baylis Medical Corp *
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 11 Oct 2016 | NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C | Device | Class II | 1 |
| 28 Oct 2015 | ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a | Device | Class II | 1 |
| 23 Sep 2013 | Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transsept | Device | Class I | 1 |
All 4 events for Baylis Medical Corp *
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution - US Nationwide in the states of MO, MA, OH, CA, AR, MA, FL, GA, CO, TX, KY, NY, MI, WI, OR"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Nov 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.