Park G03431Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002034310), received between Dec 17, 2018 and Sep 18, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (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. How this data works · Data updated Oct 13, 2026.

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.

• InjurySep 18, 2024Difficult to Open or Close; Difficult to Open or Close

  AS REPORTED, DURING A PROCEDURE INVOLVING DECOMPRESSION OF THE LEFT ATRIUM, A PARK BLADE SEPTOSTOMY CATHETER¿S BLADE WOULD NOT CLOSE PROPERLY. THE PEDIATRIC PATIENT, WHO WAS ANTI-COAGULATED, HAD MITRAL VALVE REGURGITATION AND WAS ON ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION). ANOTHER MANUFACTURER¿S 8-FRENCH SHEATH WAS USED WITH THE COMPLAINT DEVICE. THE USER TESTED THE BLADE ON THE STERILE TABLE, THROUGH THE OTHER MANUFACTURER¿S SHEATH, PRIOR TO INSERTING THE DEVICE INTO THE PATIENT, TO ENSURE THAT THE BLADE MECHANISM WORKED PROPERLY. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED PRIOR TO CATHETERIZATION, SHOWING THAT THE LEFT ATRIUM WAS SEVERELY DILATED, WITH 91-MILLILITERS OF VOLUME. A TTE PERFORMED DURING THE PROCEDURE NOTED SUBJECTIVE SEVERE DILATION OF THE LEFT ATRIUM. THE INTERATRIAL SEPTUM WAS INTACT PRIOR TO CATHETERIZATION, AND ANOTHER MANUFACTURER¿S TRANSSEPTAL RADIOFREQUENCY WIRE WAS USED PRIOR TO THE PARK BLADE. THE PHYSICIAN SUCCESSFULLY CROSSED THE ATRIAL SEPTUM AND OPENED THE BLADE WITHOUT ISSUE. CONTRAST WAS NOT INJECTED THROUGH THE CATHETER. PER THE PHYSICIAN, IMAGING DURING THE PROCEDURE WAS NOT ¿TO PAR¿ DUE TO THE CONDITION OF THE PATIENT¿S LUNGS. WHEN THE P

  Patient problems: Foreign Body In Patient

  MAUDE report 20252046 ↗
• MalfunctionDec 17, 2018Mechanical Problem

  IT WAS REPORTED THAT THE BLADE OF THE PARK BLADE SEPTOSTOMY CATHETER WAS NOT COMING OUT CORRECTLY. ANOTHER DEVICE WAS USED TO FINISH THE PROCEDURE. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8172096 ↗