FDA Medical Device Recalls (openFDA)
Baylis Medical Corp *: 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.
- Recall number
- Z-1442-2015
- Recalling firm
- Baylis Medical Corp *
- 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.
- Status
- Terminated
- Initiated
- 2015-03-30
- Posted
- 2015-04-13
- Terminated
- 2016-11-17
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- Lots CIFA180814 and CIFA080914
- 510(k) numbers
- ["K014075"]
- PMA numbers
- not on file
- Product code
- DQX
- Firm FEI
- 3005241199
- Firm city
- Montreal
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28