232 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STENT - VASCULAR RECONSTRUCTION
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code NJE·December 15, 2021
MARATHON
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·July 21, 2022
UNK - CONSTRUCTS: FNS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·September 11, 2025
UNK - CONSTRUCTS: FNS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·September 11, 2025
PERICARDIOCENTESIS KIT
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code PXU·November 18, 2025
PERICARDIOCENTESIS KIT
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS INC.·Product code PXU·July 26, 2023
PERIVAC KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code PXU·July 6, 2021
PERCARDIOCENTESIS KIT.STERILE
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS·Product code PXU·July 15, 2021
PERCARDIOCENTESIS KIT.STERILE
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS·Product code PXU·July 15, 2021
PERICARDIOCENTESIS KIT.
FDA Adverse Event
Injury
·MERIT MEDICAL RICHMOND·Product code PXU·October 22, 2024
PERICARDIOCENTESIS KIT
FDA Adverse Event
Injury
·MERIT MEDICAL RICHMOND·Product code PXU·June 18, 2025
PERICARDIOCENTESIS KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS INC.·Product code PXU·June 25, 2025
PERICARDIOCENTESIS KIT
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code PXU·March 25, 2025
PERICARDIOCENTESIS KIT.8.3F (2.77 MM).40 CM (15.7").PIGTAIL.
FDA Adverse Event
Death
·MERIT MEDICAL SYSTEMS INC.·Product code PXU·March 12, 2025
PERCARDIOCENTESIS KIT.STERILE
FDA Adverse Event
Injury
·MERIT MEDICAL RICHMOND·Product code PXU·March 16, 2022
MERIT MEDICAL PERICARDIOCENTESIS KIT - 8.3 F (2.77 MM) HIGH FLOW PIGTAIL CATHETE
FDA Adverse Event
Death
·MERIT MEDICAL SYSTEMS·Product code PXU·February 28, 2025
PERCARDIOCENTESIS KIT.STERILE
FDA Adverse Event
Injury
·MERIT MEDICAL RICHMOND·Product code PXU·March 16, 2022
PERCARDIOCENTESIS KIT.STERILE
FDA Adverse Event
Injury
·MERIT MEDICAL RICHMOND·Product code PXU·March 16, 2022
PERCARDIOCENTESIS KIT.STERILE
FDA Adverse Event
Injury
·MERIT MEDICAL RICHMOND·Product code PXU·March 16, 2022
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tray - Fluid drainage tray), REF: PC101/B PC801 PC801/A PC802 PC802/A The Pericardiocentesis Kit is intended to withdraw fluid from the pericardial sac (membrane surrounding the heart) to evaluate the fluid for diagnostic purposes or to remove excess fluid causing compression of the heart.
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code PXU·June 11, 2024