PeriVac KitRecalls & reported problems across all models

We found 4 models of PeriVac Kit by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between Oct 5, 2021 and Jun 25, 2024 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (2 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

PeriVac Kit recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-2579-2024 · Root cause: No Marketing Application · names 2 of these models · Recall details · FDA record ↗

2. 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 · names 2 of these models · Recall details · FDA record ↗

Most reported PeriVac Kit problems

PeriVac Kit models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PeriVac™ Kit 00884450486115

  Fluid drainage tray
  1 recall8 reports
• PeriVac™ Kit 00884450486139

  Universal drainage tray
  1 recall1 report
• PeriVac™ Kit 00884450486061

  Fluid drainage tray
  1 recall0 reports
• PeriVac™ Kit 00884450486122

  Universal drainage tray
  1 recall0 reports

Recent PeriVac Kit adverse event reports

The 9 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCOUNT ALLEGES THAT THE PC DRAIN WAS UNABLE TO ENTER THE PERICARDIUM DURING THE EMERGENT EFFUSION EVENT. A STIFFER DILATOR WAS OPENED AND USED. THE DRAIN WAS THEN SUCCESSFULLY INSERTED AND USED. PATIENT WAS NOT HEMODYNAMICALLY STABLE AT THE TIME.

  Patient problems: Pericardial Effusion

  MAUDE report 19608565 ↗
• 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 ↗

Other Merit Medical Systems, Inc. products

• Aspira11 models · 36 reports · 10 recalls
• Impress145 models · 481 reports
• Monarch6 models · 37 reports · 7 recalls
• Bridge Prep Kit4 models · 6 reports · 3 recalls
• Prelude Roadster33 models · 1 reports · 3 recalls
• basixTOUCH6 models · 1 reports · 3 recalls
• basixCOMPAK34 models · 34 reports · 2 recalls
• Flex-Neck11 models · 21 reports · 2 recalls