Merit Medical® 00884450015278Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00884450015278), received between Dec 1, 2020 and Nov 18, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 11, 2024Open, Classified

   Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

   Z-2569-2024 · Root cause: No Marketing Application · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Break; Fracture; Material Separation; Material Integrity Problem; Break; Fracture; Material Separation; Material Integrity Problem

  UPDATE AS OF (B)(6) 2025: THE BROKEN FRAGMENT HAS BEEN RETRIEVED BUT DISCARDED BY THE CUSTOMER FACILITY. DETAILS REGARDING THE DATE, TIME, AND METHOD FOR RETRIEVAL ARE UNKNOWN AS IT WAS DIFFICULT FOR THE CUSTOMER TO PROVIDE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23587237 ↗
• MalfunctionJun 25, 2025Gas/Air Leak; Gas/Air Leak

  THE ACCOUNT ALLEGES THE PATIENT UNDERWENT PERICARDIOCENTESIS WITHOUT ANY PROCEDURAL COMPLICATIONS. A FOLLOW UP CHEST X-RAY DEMONSTRATED A PNEUMOPERITONEUM. SUBSEQUENT CT SCAN CONFIRMED THIS WITH NO OBVIOUS PERFORATION. CONCERN IS THAT AIR WAS INTRODUCED BECAUSE OF A FAULTY STOPCOCK (3-WAY TAP) OR CONNECTION. NO ADDITIONAL PATIENT CONSEQUENCE REPORT.

  Patient problems: Pneumoperitoneum

  MAUDE report 22330211 ↗
• MalfunctionMay 20, 2025Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  THE ACCOUNT ALLEGES THAT THE DRAINAGE CATHETER WAS INSERTED SUCCESSFULLY IN THE ANGIOGRAPHY ROOM AND THEN THE PATIENT WAS TRANSFERRED TO THE FLOOR. WHEN THE PATIENT WAS ADMITTED TO THE FLOOR AROUND MIDNIGHT, IT WAS FOUND THE HUB OF THE CATHETER WAS DETACHED. IT WAS UNKNOWN WHAT KIND OF TENSION WAS APPLIED, BUT IT SEEMED TO HAVE SLIPPED OUT. THE PROCEDURE WAS COMPLETED BY REMOVING THE CATHETER AS DRAINAGE HAD BEEN COMPLETED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22055271 ↗
• InjuryOct 22, 2024Material Too Rigid or Stiff; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Material Too Rigid or Stiff; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  THE GUIDEWIRE IN USE DURING PCI THAT LED TO THE PERICARDIAL EFFUSION WAS AN .014 W /HYDROPHILIC TIP. THE PHYSICIAN STATES THAT DUE TO THE THE STIFFNESS AND CURVE OF THE PC DRAINAGE CATHETER, THE PC CATHETER ALSO CONTRIBUTED TO THE LACERATION OF THE PERICARDIUM. PERICARDIAL ACCESS WAS VIA THE SUBXIPHOID TECHNIQUE, UNDER US GUIDANCE. PROCEDURAL ACCESS WAS VIA THE RIGHT RADIAL ARTERY AND THE PATIENT'S TIME OF DEATH WAS 6:00 PM ON (B)(6) 2024.

  Patient problems: Angina; Arrhythmia; Cardiac Arrest; Cardiac Perforation; Cardiac Tamponade; Discomfort; Exsanguination; Hemorrhage/Blood Loss/Bleeding; Ischemia; Perforation; Pleural Effusion

  MAUDE report 20511136 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT AN INPATIENT EXPERIENCED HEART CHANGES THAT LED TO A CARDIAC TAMPONADE. AN EMERGENT PERICARDIOCENTESIS WAS PERFORMED BY THE CARDIOLOGY TEAM IN THE HOSPITAL ROOM TO SAVE TIME OF TRANSFER TO THE CATHETER LAB. WHILE ATTEMPTING TO INSERT THE DRAINAGE CATHETER, IT WAS CRISPY/WAVY AND COULD NOT BE INSERTED THROUGH THE PATIENT'S BODY SURFACE.

  Patient problems: Cardiac Tamponade

  MAUDE report 14861431 ↗
• InjuryJun 9, 2022Mechanical Problem; Difficult to Remove; Obstruction of Flow; Mechanical Problem; Difficult to Remove; Obstruction of Flow

  THE ACCOUNT ALLEGES THAT A PATIENT HAD BEEN RECEIVING MAINTENANCE DIALYSIS FOR END-STAGE RENAL FAILURE DUE TO NEPHROSCLEROSIS. A SCHEDULED PERICARDIOCENTESIS WAS PERFORMED ON (B)(6) 2022. AFTER THE ASPIRATION OF APPROXIMATELY 700 ML OF PALE-YELLOW PERICARDIAL FLUID, THE DEVICE WAS CONNECTED TO A DRAINAGE BAG. APPROXIMATELY 70 ML HAD BEEN REMOVED PER DAY. HOWEVER, THE DEVICE STOPPED DRAINING ON (B)(6) 2022 DESPITE ASPIRATION ATTEMPTS. A CATHETER OCCLUSION WAS SUSPECTED. ON (B)(6) 2022 THE CATHETER COULD NOT BE REMOVED DUE ANATOMICAL TORTUOSITY. ON THE SAME DAY ((B)(6) 2022), SURGICAL REMOVAL OF THE PC CATHETER WAS PERFORMED UNDER GENERAL ANESTHESIA AND MINI-THORACOTOMY OF THE STERNUM WAS COMPLETED. A FIBRIN SHEATH WAS NOTED TO HAVE ATTACHED AROUND THE DRAIN AND WAS REMOVED BY THE SURGEON. THE PATIENT TOLERATED THE PROCEDURE AND POSTSURGICAL RECOVERY WELL. EXTUBATING THE PATIENT WAS COMPLETED IMMEDIATELY AFTER THE SURGICAL PROCEDURE. THE PATIENT WAS TRANSFERRED FROM ICU TO A GENERAL WARD THE NEXT DAY. POSTOP CLINICAL COURSE IS FAVORABLE. DEVICE WAS DISCARDED AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14645588 ↗
• InjuryDec 1, 2020Material Fragmentation; Material Separation; Material Fragmentation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN EMERGENT PERICARDIAL DRAINAGE PROCEDURE FOR A CARDIAC TAMPONADE THE TIP OF THE CATHETER GOT DETACHED DURING THE WITHDRAWAL. THE TIP REMAINED IN THE PATIENT'S BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10928922 ↗