PeriVac™ Kit 00884450486115Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00884450486115), received between Oct 5, 2021 and Apr 4, 2023 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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. 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-2565-2024 · Root cause: No Marketing Application · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE REPORT PUBLISHED IN JUNE/JULY 2021 INDICATED THAT AN 80-YEAR OLD WOMAN WITH A HISTORY OF PERSISTENT ATRIAL FIBRILLATION UNDERWENT THE LARIAT LEFT ATRIAL APPENDAGE (LAA) LITIGATION PROCEDURE. THE PROCEDURE WAS UNEVENTFUL AND AT THE END A STRAIGHT PERICARDIAL DRAIN WAS PLACED TO ALLOW FURTHER EVACUATION OF THE SPACE FROM THE LIGATED LAA. THE PATIENT DID WELL FOR THE FIRST 18 HOURS WITH NO FURTHER DRAINAGE. THE NEXT MORNING, THE PATIENT COMPLAINED OF SIGNIFICATION CHEST PAIN AND MANY BOUTS OF DEEP COUGHING. IMMEDIATELY AFTER THAT THE PATIENT'S PERICARDIAL DRAIN STARTING PUTTING OUT A SIGNIFICANT AMOUNT OF DARK VENOUS BLOOD SUGGESTIVE OF POSSIBLE RECURRENT PERICARDIAL EFFUSION. A TRANSTHORACIC ECHOCARDIOGRAPHY DID NOT REVEAL ANY PERICARDIAL FLUID. THE PATIENT WAS EXAMINED UNDER FLUOROSCOPY WHERE THE TIP OF THE DRAIN WAS NOT CLEARLY VISIBLE IN THE PERICARDIAL SPACE. CONTRAST INJECTION THROUGH PERICARDIAL DRAIN CONFIRMED ITS LOCATION IN THE HEPATIC VEIN INFERIOR VENA CAVA (IVC) CONFLUENCE. COMPUTED TOMOGRAPHY(CT) ALSO WAS PERFORMED AND IDENTIFIED THAT THE PERICARDIAL DRAIN HAS MIGRATED INTO THE IVC AND THE TIP WAS IN THE MIDDLE HEPATIC VEIN. THIS CONFIRMED THE MIGRATION OF THE PER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675237 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THEY HAD AN ISSUE WITH PERFORATIONS DURING PROCEDURES. NO ADDITIONAL INFORMATION ABOUT THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15714411 ↗
• MalfunctionSep 20, 2022Difficult to Advance; Material Too Soft/Flexible; Difficult to Advance; Material Too Soft/Flexible

  THE ACCOUNT ALLEGES THEY EXPERIENCED DIFFICULTY ADVANCING THE CATHETER OVER THE WIRE IN THE PERICARDIAL SPACE DUE TO THE CATHETER IN THE KIT BEING 'TOO FLIMSY'. THE PATIENT WAS EXPERIENCING PERICARDIAL TAMPONADE SO THE CLINICAN USED AN INQWIRE AMPLATZ STIFF GUIDE WIRE TO SUCCESSFULLY ADVANCE THE CATHETER IN TOT HE PERICARDIAL SPACE. THE PROCEDURE WAS SUCCESSFUL AND THERE IS NO ADDITIONAL PATIENT CONSEQUENCE WAS TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15455318 ↗
• InjuryMar 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT THE DEVICE DIDN'T ADEQUATELY DRAIN THE FLUID FROM THE PATIENT'S PAERICARDIAL SACK DURING THE PROCEDURE. THE DEVICE WAS REPLACED WITH ANOTHER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13778743 ↗
• InjuryMar 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT THE DEVICE DIDN'T ADEQUATELY DRAIN THE FLUID FROM THE PATIENT'S PAERICARDIAL SACK DURING THE PROCEDURE. THE DEVICE WAS REPLACED WITH ANOTHER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13778742 ↗
• InjuryMar 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT THE DEVICE DIDN'T ADEQUATELY DRAIN THE FLUID FROM THE PATIENT'S PAERICARDIAL SACK DURING THE PROCEDURE. THE DEVICE WAS REPLACED WITH ANOTHER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13778738 ↗
• InjuryMar 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT THE DEVICE DIDN'T ADEQUATELY DRAIN THE FLUID FROM THE PATIENT'S PAERICARDIAL SACK DURING THE PROCEDURE. THE DEVICE WAS REPLACED WITH ANOTHER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13778733 ↗
• InjuryOct 5, 2021Difficult or Delayed Positioning; Difficult to Advance; Difficult or Delayed Positioning; Difficult to Advance

  THE ACCOUNT ALLEGES THAT THE PROVIDER DIAGNOSED A PERICARDIAL EFFUSION DURING AN ELECTROPHYSIOLOGY PROCEDURE ON (B)(6) 2021. A PERIVAC KIT WAS OPENED AND ACCESS TO THE PERICARDIAL SPACED WAS OBTAINED VIA NEEDLE AND WIRE PROVIDED IN KIT. HOWEVER, THE CATHETER WAS NOT ABLE TO ADVANCE OVER THE WIRE AND INTO THE PERICARDIAL SPACE. SINCE THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE NEW CATHETER INTO POSITION, THE EFFUSION CONTINUED TO IMPACT THE PATIENT HEMODYNAMICALLY. THEREFORE, THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM TO ADDRESS THE EFFUSION SURGICALLY.

  Patient problems: Pericardial Effusion

  MAUDE report 12576887 ↗