The Recall Desk

Manufacturer

Baylis Medical Corp *

4 recalls in our database name Baylis Medical Corp * as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2016-11-16

Of the 4 recalls from Baylis Medical Corp * we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–4 of 4

  • ModerateFDA (Devices)·Z-0393-2017·2016-11-16

    Baylis Medical Recalls NRG Transseptal Needles Due to Packaging Defect

    Baylis Medical Corp is voluntarily recalling NRG Transseptal Needles and RF Kits because the Tyvek packaging pouches may have integrity defects.

    Product
    NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-98-C1-T, NRG-E-56-32-C0, and NRG-E-HF-71-C0. The NRG Transseptal Needle is packaged onto a thermoformed tray with
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0356-2016·2015-12-09

    Baylis ProTrack Microcatheter Recalled for Circumferential Shaft Cracks

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

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2015·2015-04-22

    Baylis Medical Recalls ProTrack Microcatheter Due to Circumferential Shaft Defects

    Baylis Medical Corp is recalling two lots of ProTrack Microcatheters due to potential circumferential defects along the device shaft.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0085-2014·2013-11-13

    Baylis Medical Recalls TorFlex Transseptal Guiding Sheath Kits

    Baylis Medical is recalling TorFlex Transseptal Guiding Sheath Kits because the sheath may remove particulate from the dilator, which could migrate into a patient's bloodstream.

    Product
    Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed fo
    Category
    Medical Device
    Distribution
    Distributed nationwide