Royal Flush G04894Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002048942), received between Aug 3, 2017 and Apr 4, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (3 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PACKAGING OF THE 'ROYAL FLUSH PLUS FLUSH CATHETER' WAS DAMAGED. THE ISSUE WAS DISCOVERED DURING DISTRIBUTION, THEREFORE, THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773732 ↗
• InjuryFeb 28, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS REPORTED, DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE, A ROYAL FLUSH PLUS FLUSH CATHETER'S PEEL-AWAY STRAIGHTENER WAS LEFT IN THE PATIENT. AFTER ADVANCEMENT OVER AN UNSPECIFIED 0.035-INCH WIRE GUIDE, THE CATHETER'S PEEL AWAY STRAIGHTENER WAS PULLED BACK BUT WAS NOT REMOVED FROM THE CATHETER. RESISTANCE WAS NOT ENCOUNTERED WITH MANIPULATION OR ADVANCEMENT OF THE CATHETER DURING THE PROCEDURE, DURING WHICH SIX-TO-NINE-FRENCH SHEATHS WERE USED. PER THE PHYSICIAN, THE PEEL-AWAY STRAIGHTENER WAS LEFT ON THE CATHETER AND USED "AGAIN AND AGAIN" FOR REINSERTION OF THE SAME CATHETER DURING THE "COMPLEX, LONG" PROCEDURE. REPORTEDLY, THE POST-OPERATIVE COURSE WAS UNEVENTFUL; HOWEVER, THE PATIENT WAS READMITTED THROUGH THE EMERGENCY DEPARTMENT SIX DAYS AFTER THE EVAR PROCEDURE WITH GROIN AND LOWER ABDOMINAL PAIN. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SCAN REVEALED A FOREIGN BODY IN THE LEFT FEMORAL ARTERY. THE PEEL-AWAY STRAIGHTENER WAS THEN REMOVED FROM THE PATIENT DURING A SURGICAL PROCEDURE. PER THE PHYSICIAN, IT IS BELIEVED THAT THE PEEL-AWAY STRAIGHTENER "SLIPPED IN" THROUGH THE ARTERIAL SHEATH DURING THE EVAR PROCEDURE AND REMAINED WITHIN THE ARTERY AFTER THE CATHETER WA

  Patient problems: Foreign Body In Patient

  MAUDE report 16456970 ↗
• MalfunctionJul 7, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 10240544 ↗
• MalfunctionJan 15, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE USER EXAMINED THE PACKAGE AND FOUND THE TIP OF THE ROYAL FLUSH PLUS FLUSH CATHETER WAS BROKEN. THE USER CHANGED TO ANOTHER ONE TO CONTINUE. THE COMPLAINT DEVICE NEVER MADE PATIENT CONTACT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8247714 ↗
• MalfunctionAug 3, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING INSPECTION, THE PRIMARY PACKAGING WAS OBSERVED TO BE PUNCTURED.

  Patient problems: No Patient Involvement

  MAUDE report 6765993 ↗
• MalfunctionAug 3, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING INSPECTION, THE PRIMARY PACKAGING WAS OBSERVED TO BE PUNCTURED.

  Patient problems: No Patient Involvement

  MAUDE report 6765950 ↗