Recalls and Safety Alerts:
PENTAX Medical Gas/Water Valves, Model OF-B194: Recall
The OF-B194 Valve has been found to have a manufacturing defect which may prevent users from turning off the CO2 gas flow during an endoscopic procedure, with the potential for serious hazard to the patient…
Baylis Medical TorFlex Transseptal Guiding Sheath Kit: Class I Recall
The sheath could remove particulate of less than 5 mm from the dilator…
Edwards Lifesciences LLC, EMBOL-X Glide Protection System: Class I Recall
The tip of the catheter is being recalled due to a deformed cannula tip…
Fabius Anesthesia Machines: Recall
In extreme cases, the influence of mechanical forces, such as movement of the device, for example, may cause a failure of the automatic ventilation function of the device…
Avance, Aisys And Avance CS2 Anesthesia Delivery Systems: Voluntary Field Corrective Action
GE Healthcare has initiated a voluntary field corrective for the Avance, Aisys and Avance CS2 anesthesia delivery systems with 8.00 (Avance and Aisys) or 10.00 (Avance CS2) software due to a potential safety issue…
Engstrom Ventilator, Aespire View, Aisys, And Avance Anesthesia Machines: Voluntary Field Corrective Action
Due to a manufacturing issue the buttons on the left, right, and bottom keypads may not always detect a user’s button presses…
St. Jude Amplatzer Atrial Septal Occluder (ASO): Safety Communication
In very rare instances, tissue surrounding the Amplatzer ASO can break down (erode) and result in life-threatening emergencies that require immediate surgery…
Bard LifeStent Solo Vascular Stent: Class 1 Recall
Recall due to deployment issues that range from failure to deploy, partial deployment, and difficult deployment…
MedStream Programmable Infusion Pump and Refill Kits by Codman and Shurtleff: Class 1 Recall
Recall due to air in the pump reservoir which may release a higher dosage of drug than expected, leading to drug overdose…
Discussions with Healthcare Providers:
da Vinci Surgical System: Small Sample Survey Summary
The purpose of this survey is to enhance FDA’s understanding of surgeons' perspectives on the da Vinci Surgical System...
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