There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.
Surgical Instruments
π₯ Medical Devices β’ 6,839 recalls
May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue damage or other delayed secondary complications including infection, peritonitis, and sepsis
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
IceSeed" 1.5 Cryoablation Needle
Boston Scientific
Complaint trend regarding needle shaft gas leaks.
IcePearl" 2.1 CX 90ΒΏ Cryoablation Needle
Boston Scientific
Complaint trend regarding needle shaft gas leaks.
IceRod" 1.5 CX 90ΒΏ Cryoablation NeedleΒΏ
Boston Scientific
Complaint trend regarding needle shaft gas leaks.
IcePearl" 2.1 CX Cryoablation Needle
Boston Scientific
Complaint trend regarding needle shaft gas leaks.
Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
Device has the potential for fracture during use.
IceRod" 1.5 i-Thaw" Cryoablation Needle
Boston Scientific
Complaint trend regarding needle shaft gas leaks.
IceSeed" 1.5 90ΒΏ Cryoablation Needle
Boston Scientific
Complaint trend regarding needle shaft gas leaks.
IceSeed" 1.5 MRI Cryoablation Needle
Boston Scientific
Complaint trend regarding needle shaft gas leaks.
STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2
GA HEALTH COMPANY LIMITED
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
IceSphere" 1.5 CX 90ΒΏ Cryoablation Needle
Boston Scientific
Complaint trend regarding needle shaft gas leaks.
IceSphere" 1.5 Cryoablation Needle
Boston Scientific
Complaint trend regarding needle shaft gas leaks.
IceSphere" 1.5 S 90ΒΏ Cryoablation Needle
Boston Scientific
Complaint trend regarding needle shaft gas leaks.
IceFORCE" 2.1 CX 90ΒΏ Cryoablation Needle
Boston Scientific
Complaint trend regarding needle shaft gas leaks.
IceRod" 1.5 PLUS 90ΒΏ Cryoablation Needle
Boston Scientific
Complaint trend regarding needle shaft gas leaks.
Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not stop when releasing the button, result in potential risk to the patient's eye