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Baylis Medical Corp * Recalls
4 recalls on record · November 13, 2013 to November 16, 2016 · Medical Devices
Recalls by year
13
15
16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 16, 2016Medical DevicesFDA
Baylis Medical Corp * recalls NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-8
Hazard: The firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit due to the possibility for an integrity defect to the Tyvek pouch of the NRG Transseptal Needle.
December 9, 2015Medical DevicesFDA
Baylis Medical Corp * recalls ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as
Hazard: Microcatheter may have circumferential defects (cracks) along its shaft.
April 22, 2015Medical DevicesFDA
Baylis Medical Corp * recalls ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be us
Hazard: Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects along its shaft.
November 13, 2013Medical DevicesFDA
Baylis Medical Corp * recalls Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Trans
Hazard: The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patients bloodstream.