DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
Medtronic Perfusion Systems
Class I - Dangerous
Potential for a wire protrusion through the left heart vent catheter tip
🔪
Surgical Instruments
🏥 Medical Devices • 6,839 recalls
Class I - Dangerous
There is potential for packaging defects that may impact the sterile barrier.
Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.
Argon Medical Devices
Class I - Dangerous
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
Soft Tissue Biopsy Needles
M.D.L. S.r.l.
Class I - Dangerous
Sterility assurance may be compromised.
Class I - Dangerous
There is potential for packaging defects that may impact the sterile barrier.
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Medtronic Perfusion Systems
Class I - Dangerous
Potential for a wire protrusion through the left heart vent catheter tip
Class I - Dangerous
There is potential for packaging defects that may impact the sterile barrier.
Class I - Dangerous
There is potential for packaging defects that may impact the sterile barrier.
10 ga ARS Decompression Needle, Part Number ZZ-0298
North American Rescue
Class I - Dangerous
The device includes the incorrect Instructions for Use.
General Manual surgical instrument
M.D.L. S.r.l.
Class I - Dangerous
Sterility assurance may be compromised.
Aspirated Cyto-Histological Biopsy needle
M.D.L. S.r.l.
Class I - Dangerous
Sterility assurance may be compromised.
Bone Marrow Transplantation biopsy needle
M.D.L. S.r.l.
Class I - Dangerous
Sterility assurance may be compromised.
Class I - Dangerous
Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
Class I - Dangerous
Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
Class I - Dangerous
Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
Class I - Dangerous
Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement.
Class I - Dangerous
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
Class I - Dangerous
Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement.
Class I - Dangerous
Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement.