ProGuide™ 00884450023426Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00884450023426), received between Mar 19, 2020 and May 23, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  THE ACCOUNT ALLEGES THAT DURING A DIALYSIS PROCEDURE ON A 45YO MALE PATIENT, A LONG-TERM HEMODIALYSIS CATHETER IN THE PATIENT'S RIGHT NECK WAS FIXED IN PLACE. THE CATHETER END WAS USED TO WITHDRAW FLUID SMOOTHLY FOR PREPARATION OF DIALYSIS. THERE WAS A NOTED CRACK IN THE THREADS OPENING AT THE ARTERIAL END, ABOUT 1CM. THE WITHDRAWAL OF FLUID WAS SMOOTH AND ACCOMPANIED BY CONTINUOUS AIR BUBBLES. THIS WAS IMMEDIATELY REPORTED TO THE PHYSICIAN ON DUTY. THE PHYSICIAN WANTED TO SEAL THE PATIENT'S TUBE FOR CONTINUED USE AND EVENTUALLY REPLACE THE CATHETER WHEN POSSIBLE. NO INJURY OF THE PATIENT TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16985924 ↗
• MalfunctionApr 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DIALYSIS CATHETER LEAKED POST PROCEDURE FROM THE HUB. THE CATHETER WAS INSERTED 6 MONTHS AGO. THE CATHETER WAS REMOVED AND A NEW ONE IMPLANTED. NO INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16717437 ↗
• MalfunctionMar 30, 2022Crack; Crack

  THE ACCOUNT ALLEGES THAT A DIALYSIS CATHETER WAS PLACED LESS THAN TWO MONTHS AGO. DURING DIALYSIS, THE STAFF NOTICED A CRACK IN THE LUER OF THE CATHETER. THE CATHETER WAS CHANGED OUT FOR A NEW ONE WITH NO COMPLICATIONS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13953517 ↗
• MalfunctionJun 18, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT THE HUB ON THE CHRONIC DIALYSIS CATHETER WAS CRACKED AND LEAKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10171726 ↗
• MalfunctionJun 18, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT THE HUB ON THE CHRONIC DIALYSIS CATHETER WAS CRACKED AND LEAKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10171724 ↗
• MalfunctionJun 18, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT THE HUB ON THE CHRONIC DIALYSIS CATHETER WAS CRACKED AND LEAKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10171723 ↗
• MalfunctionMar 19, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AND ATTEMPTED DIALYSIS TREATMENT PROCEDURE, THE ENDCAPS DETACHED FROM THE CATHETER. THE PATIENT HAD THE DIALYSIS CATHETER PLACED AT THE SAME FACILITY ON (B)(6) 2020. THE PATIENT'S ANATOMY WAS EXTREMELY CHALLENGING DURING PLACEMENT. DURING ATTEMPTS TO REMOVE THE END CAPS FROM THE CATHETER ON (B)(6) 2020 AT THE DIALYSIS CENTER, THE CAPS BECAME STUCK. DURING ADDITIONAL REMOVAL ATTEMPTS, THE CATHETER HUB DETACHED FROM THE CATHETER. THE PATIENT WAS DOING FINE AND WAS SENT TO A LOCAL HOSPITAL FOR A NEW CATHETER EXCHANGE BECAUSE THE DIALYSIS CENTER WAS CLOSING. THE PATIENT WAS AN OUT-PATIENT IN RADIOLOGY, THE CATHETER WAS RE-WIRED, AND A NEW CATHETER WAS PLACED. NO PATIENT INJURY TO REPORT. PATIENT TOLERATED THIS PROCEDURE WELL. DIALYSIS WAS COMPLETED THE NEXT MORNING AT THE CENTER WITHOUT ADDITIONAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9857536 ↗