Merit Medical® 00884450054017Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450054017), received between Jul 15, 2021 and Jul 15, 2021 — classified as 2 injuries.

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

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 11, 2024Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE ACCOUNT ALLEGES THAT A PERICARDIOCENTESIS PROCEDURE WAS PERFORMED AT PATIENT'S BEDSIDE WITHIN THE UNIT FOR SUBACUTE CARDIAC TAMPONADE. THE PHYSICIAN FAILED TO ACQUIRE ACCESS TO THE PATIENT'S PERICARDIUM WITH THE 8.3F PIGTAIL CATHETER. THE PHYSICIAN HAD A DIFFICULT TIME ADVANCING THE DRAINAGE CATHETER TO THE PERICARDIUM OVER-THE-ACCESS WIRE. THE PHYSICIAN HAD TO USE ADDITIONAL FORCE WITH THE DILATOR/GUIDEWIRE WHICH POSSIBLY RESULTED IN THE PUNCTURE/PERFORATION OF THE PATIENT'S RIGHT VENTRICLE. THE ACCOUNT AGREES THAT AN INADEQUATE NUMBER OF DILATORS WERE AVAILABLE TO PROPERLY DILATE THE PERICARDIUM DUE TO THE FACT THIS PROCEDURE WAS PERFORMED AT PATIENT'S BED SIDE AND NOT IN CATHLAB SETTING. THE PATIENT WAS TRANSFERRED TO SURGICAL UNIT FOR URGENT THORACOTOMY AFTER RIGHT VENTRICULAR PERFORATION. PATIENT WAS DOING WELL TWO WEEKS POST-SURGICAL FOLLOW UP. DEVICE WAS DISCARDED AND WILL NOT BE RETURNING FOR EVALUATION. THE REPORTING NURSE STATES THAT THIS PATIENT HAS A HISTORY OF RADIATION THERAPY TO CHEST THAT WOULD HAVE CAUSED A LOT OF SCAR TISSUE/FIBROUS TISSUE FORMATION RESULTING IN EXTREME DIFFICULTY IN ACQUIRING ACCESS DURING PERICARDIOCENTESIS ATTEMPTS. HISTORICALLY, DIFFICULT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12174199 ↗
• InjuryJul 15, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT A SCHEDULED PERICARDIOCENTESIS PROCEDURE IN THE EP LAB FOR AN ELDERLY FEMALE PATIENT DIAGNOSED WITH CARDIAC TAMPONADE WAS SUCCESSFULLY COMPLETED. THE ACCESS APPROACH WAS "APICAL" AND WAS COMPLETED UNDER FLUOROSCOPY. BOTH THE GUIDEWIRE AND DILATOR WITHIN THE KIT WERE USED DURING THE PROCEDURE TO ACQUIRE PC CATHETER ACCESS. NO ANATOMICAL VARIATIONS WERE EXPERIENCED OR DIFFICULTIES IN INFILTRATING THE PATIENT'S PERICARDIUM. THE ACCOUNT ALLEGES THAT DURING THE PC CATHETER REMOVAL, RESISTANCE WAS EXPERIENCED BY THE PHYSICIAN. ADDITIONAL INTERVENTIONS TO REMOVE THE CATHETER SAFELY WERE INITIATED HOWEVER, THE TIP OF THE PIG TAIL DRAINAGE CATHETER DETACHED, JUST DISTAL TO THE MARKER BAND WITHIN THE PATIENT'S PERICARDIUM. CT SURGERY ASSISTED IN TRYING TO REMOVE THE FOREIGN BODY FROM THE PATIENT. A VASCULAR SNARE DEVICE WAS UTILIZED UNSUCCESSFULLY. A DRAINAGE TUBE WAS PLACED, AND THE PATIENT WAS TRANSFERRED TO ICU FOR THORACIC SURGERY CONSULTATION. IT IS LIKELY SURGICAL INTERVENTION [STERNOTOMY] WILL BE NEEDED IF THE PATIENT CAN TOLERATE THE PROCEDURE. ALL PARTS OF THE PC CATHETER HAVE BEEN DISCARDED. NOTHING AVAILABLE TO RETURN FOR INVESTIGATION. THE PATIENT HAS SIN

  Patient problems: Foreign Body In Patient

  MAUDE report 12174195 ↗