Baylis Medical Company Inc.
FDA adverse event reports naming Baylis Medical Company Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BAYLIS MEDICAL COMPANY INC..
- Total reports
- 1,304
- Deaths
- 57
- Injuries
- 854
- Malfunctions
- 393
Reports per year
Source: FDA adverse event reports by year received, 2015–2024. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Catheter, SeptostomyDXF670
- Dilator, Vessel, For Percutaneous CatheterizationDRE300
- Introducer, CatheterDYB227
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI47
- Wire, Guide, CatheterDQX32
- Catheter For Crossing Total OcclusionsPDU12
- ArthroscopeHRX7
- Catheter, PercutaneousDQY3
- Probe, Radiofrequency LesionGXI3
- Sperm, Fitc, Antigen, Antiserum, ControlDFX1
Recent recalls
- 2020-05-21TerminatedPackage design/selection
TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135, TF85-32-63-37, TF85-32-63-45, TF85-32-63-55, TF85-32-63-90, TF85-32-63-135, TF8-32-81-45, TF8-32-81-55, TF8-32-81-90, TF85-32-81-37, TF85-32-81-45, TF85-32-81-55, and TF85-32-81-90.
There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient, there may be a remote risk of infection.
- 2020-05-21TerminatedPackage design/selection
NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N and NTK-711-8555N.
There is a remote potential for the sterile packaging of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient, there may be a remote risk of infection.
- 2013-02-26TerminatedPackaging
BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain.
A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually packaged cannula had not been sealed along one edge. Thus the pouch was open and the device could fall out of the pouch and on to the floor when retrieved from the shelf box. The cannulas were not used on any patients, as the unsealed packages
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