Merit Medical® 00884450013465Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884450013465), received between Apr 14, 2021 and Oct 7, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Complete Blockage” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 2024Fracture; Difficult to Insert; Difficult to Advance; Fracture; Difficult to Insert; Difficult to Advance

  THE ACCOUNT ALLEGES THAT DURING A PERICARDIOCENTESIS PROCEDURE, THE DRAINAGE CATHETER COULD NOT BE INTRODUCED INTO THE PATIENTS PERICARDIUM. THE DISTANCE BETWEEN THE DRAINAGE CATHETER TIP AND INTRODUCER WAS TOO LARGE, SO THE DRAINAGE CATHETER COULD NOT BE ADVANCED THROUGH THE ACCESS INCISION. THE THREE-WAY STOPCOCK OUTSIDE THE PATIENT WAS TOO DIFFICULT TO TURN, IT CRACKED/BROKE ON THE INSIDE OF THE STOPCOCK. THE DEVICE WAS DISCARDED AT THE ACCOUNT AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20392836 ↗
• InjuryJul 26, 2023Obstruction of Flow; Obstruction of Flow

  THE ACCOUNT ALLEGES THAT AT THE END OF A CRYOTHERAPY PROCEDURE FOR ABLATION OF PAROXYSMAL ATRIAL FIBRILLATION, THE PATIENT WAS UNRESPONSIVE TO SIMPLE COMMANDS. THE CLINICAL TEAM SUSPECTED CARDIAC TAMPONADE. CPR WAS ADMINISTERED AND THE PATIENT WAS INTUBATED. TWO ATTEMPTS TO PERFORM A PERICARDIOCENTESIS WERE ATTEMPTED BY THE ATTENDING PHYSICIAN. FIRST ATTEMPT: PERICARDIAL PUNCTURE IS UNSUCCESSFULLY ATTEMPTED WITH THE 18G PINK NEEDLE. THE PRACTITIONER STATES THAT THE NEEDLE MAY BE CLOGGED; IT WAS IMPOSSIBLE TO PULL BACK ON THE PLUNGER OF THE SYRINGE. SECOND ATTEMPT: PERICARDIAL PUNCTURE IS ATTEMPTED WITH A PINK SPINOCAN 18GG 88MM NEEDLE REFERENCE 4501390 FROM BBRAUN. THIS ATTEMPT WAS SUCCESSFUL, AND THE PROCEDURE WAS COMPLETED WITH 90 ML'S OF BLOOD REMOVED FROM THE PATIENT'S PERICARDIAL SACK. THE SAME SYRINGE WAS USED WITH BOTH NEEDLES. THE PATIENT'S VITAL SIGNS IMPROVED.

  Patient problems: Cardiac Tamponade

  MAUDE report 17399140 ↗
• InjuryJun 10, 2022Material Too Soft/Flexible; Material Too Soft/Flexible

  THE ACCOUNT ALLEGES THAT DURING AN EMERGENT PERICARDIOCENTESIS PROCEDURE, IT WAS STATED THAT THE CATHETER WAS TOO SOFT. THE PATIENT WAS HEMODYNAMICALLY UNSTABLE AND DIAGNOSED WITH CARDIAC TAMPONADE AT THE TIME. THE CATHETER WAS DISCARDED, AND A NEW KIT WAS OPENED AND USED TO COMPLETE THIS PROCEDURE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14652208 ↗
• InjuryJun 9, 2022Unraveled Material; Unraveled Material

  THE ACCOUNT ALLEGES THAT DURING AN EMERGENT PERICARDIOCENTESIS PROCEDURE, THE ACCESS GUIDEWIRE COIL STARTED TO UNRAVEL. THE PATIENT WAS HEMODYNAMICALLY UNSTABLE AND DIAGNOSED WITH CARDIAC TAMPONADE AT THE TIME. THE ACCESS WIRE WAS DISCARDED, AND A NEW KIT WAS OPENED AND USED TO COMPLETE THIS PROCEDURE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14641293 ↗
• InjuryApr 14, 2021Complete Blockage; Complete Blockage

  THE ACCOUNT ALLEGES THAT DURING AN EMERGENT PERCUTANEOUS PERICARDIOCENTESIS FOR LIFE THREATENING CARDIAC TAMPONADE, THE DRAINAGE CATHETER COULD NOT BE SUCCESSFULLY INTRODUCED. THE PHYSICIAN USED A LOCAL ANESTHETIC TO NUMB THE ACCESS AREA [ SUBXIPHOID APPROACH] OF THE PATIENT'S CHEST. A NEEDLE WAS THEN INSERTED, VIA "SELDINGER TECHNIQUE", UNDER THE GUIDANCE OF AN ECHO/FLUOROSCOPY, INTO THE PATIENT'S PERICARDIAL SACK. A GUIDEWIRE WAS INSERTED INTO THE PATIENT PERICARDIUM AND THE ACCESS NEEDLE SUCCESSFULLY REMOVED. WHEN THE PHYSICIAN TRIED TO INTRODUCE THE DRAINAGE CATHETER, OVER THE "J" WIRE INTO THE PATIENT'S PERICARDIUM, THE DRAINAGE CATHETER WOULD NOT ALLOW THE ACCESS WIRE THROUGH THE CATHETER'S INNER LIMEN. THE ACCOUNT ALLEGES THAT THE DISTAL PART OF THE DRAINAGE CATHETER WAS OBSTRUCTED. ANOTHER CATHETER WAS EXPEDITIOUSLY PREPPED AND SUCCESSFULLY USED TO TREAT THIS PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667598 ↗