Permcath 8817749001Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20884521009872), received between Sep 3, 2020 and Sep 27, 2024 — classified as 7 malfunctions.

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

• MalfunctionSep 27, 2024Material Puncture/Hole; Pumping Problem; Material Puncture/Hole; Pumping Problem

  ACCORDING TO THE REPORTER, AFTER SURGERY, BLOOD LEAKAGE WAS FOUND IN THE SILICONE TUBE OF THE INTRAVENOUS CONNECTOR. THE CATHETER WAS NOT REPAIRED. THERE WAS A LEAK AT THE VENOUS CONNECTOR SILICONE TUBE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20323450 ↗
• MalfunctionAug 26, 2024Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING CATHETER INSERTION, WHEN THE LONG-TERM DOUBLE-LUMEN CATHETER WAS LED OUT OF THE TUNNEL, THE TUNNEL DEVICE CONNECTOR BROKE (THE TUNNEL DEVICE STEEL BAR WAS DISCONNECTED FROM THE PLASTIC CONNECTOR), RESULTING IN THE CATHETER BEING UNABLE TO PASS THROUGH THE TUNNEL AND THE OPERATION BEING UNABLE TO CONTINUE. THE IMPACTS ON THE PATIENT WERE EXTENDED OPERATION TIMES, INCREASED BLEEDING, AND INCREASED MEDICAL EXPENSES. A TEMPORARY CATHETER WAS USED INSTEAD, OR A SECOND SET OF PRODUCTS WAS USED. AT THAT TIME, IT WAS DECIDED TO USE A TEMPORARY HEMODIALYSIS CATHETER TO QUICKLY ESTABLISH DIALYSIS ACCESS. THE PATIENT'S CONDITION IMPROVED AFTER RECEIVING DIALYSIS TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20071260 ↗
• MalfunctionFeb 7, 2024Break; Break

  ACCORDING TO THE REPORTER, AFTER SURGERY, THERE WERE CRACKS AND BLOOD LEAK AT THE CATHETER MAIN BODY SPECIFICALLY AT THE SLEEVE. THE LEAKAGE WAS LOCATED OUTSIDE THE BODY. THERE WAS NO LEAK AT THE JUNCTION OF THE BIFURCATE AND CATHETER. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. BESIDES THE REPORTED ISSUE THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. FLUSHING WAS NOT DONE PRIOR TO USE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. SEPSIDERM WAS NOT USED TO CLEAN THE CATHETER. THERE WAS NO OINTMENT(S) UTILIZED AT THE EXIT SITE. WOUND DRESSING WAS NOT UTILIZED. THE TREATMENT (LOTIONS/OINTMENTS, MEDICATIONS) WAS NOT USED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE PATIENT WAS TREATED UNDER LOCAL ANESTHESIA. THE CATHETER WAS NOT REPAIRED. AS A REMEDIAL ACTION THE REPORTED CATHETER WAS EXPLANTED AND REPLACED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO MEDICAL INTERVENTION/TREATMENT DONE TO THE PATIENT AS A RESULT OF THE EVENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS RELATED TO TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664513 ↗
• MalfunctionJun 23, 2023Break; Break

  ACCORDING TO THE REPORTER, DUE TO UREMIA, THE PATIENT HAD A SEMI-PERMANENT CATHETER PLACED IN THE RIGHT NECK, AND DURING THE HEMODIA LYSIS PROCESS, THE DOCTOR FOUND A SMALL AMOUNT OF BLOOD OOZING FROM THE CATHETER. THEY CHECKED THE CATHETER IMMEDIATELY AND FOUND THAT THE VENOUS LUER ADAPTER OF THE CATHETER WAS SPLIT (A MATERIAL FRACTURE OR BREAK). NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE PRODUCT WAS FLUSHED PRIOR TO USE, AND THE RESULT WAS NORMAL: THE FITTINGS WERE CLEAN AND IT WAS FLUSHED PROPERLY. THE ADAPTERS WERE HAND-TIGHTENED. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. SALINE WAS THE CLEANING AGENT USED ON THE DEVICE, AND IT WAS TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. TEGO WAS NOT UTILIZED. THEY IMMEDIATELY GAVE BACK BLOOD TO GET OFF THE MACHINE, SEALED THE TUBE WITH HEPARIN, AND THE PROCESS WENT SMOOTHLY. THE DOCTOR WHO PLACED THE CATHETER WAS CONTACTED AND CONSIDERED REPLACING THE CATHETER TIP AT AN OPTIONAL TIME, AND THE PATIENT WAS INFORMED OF THE RELEVANT PRECAUTIONS AND THAT IF THERE WERE SPECIAL CIRCUMS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195549 ↗
• MalfunctionApr 3, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING CATHETERIZATION, WHEN THE GUIDEWIRE WITHIN THE KIT WAS IMPLANTED, IT WAS STUCK IN THE NEEDLE AND CANNOT BE IMPLANTED OR WITHDRAWN. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. FLUSHING WAS PERFORMED AND IT WAS FULLY FLUSHED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. TEGO WAS NOT UTILIZED AND NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE. THE CLEANING AGENT USED ON THE DEVICE WAS SALINE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. AS A RESULT OF THE EVENT, HEMOSTASIS AND RE-CANNULATION WITH ANOTHER HEMODIALYSIS CATHETER WAS REQUIRED AS AN INTERVENTION. THERE WAS A BLOOD LOSS OF ABOUT 5 MILLILITER (ML), AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE TREATMENT WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16664057 ↗
• MalfunctionFeb 23, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING CATHETER INSERTION, A HEMATIC LEAK WAS DETECTED AT THE JUNCTION OF EXTENSION TUBE AND HUB (UNION BETWEEN ARTERIAL AND VENOUS EXTENSION TUBE). THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, THERE WERE NO DAMAGES FOUND ON THE PRODUCT AND NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE. THEY USED ON ANOTHER CATHETER TO RESOLVE THE ISSUE AND PROCEDURE WAS COMPLETED. THERE WAS A LITTLE AMOUNT (NOT MUCH) OF BLOOD AS THEY REMOVED THE CATHETER INSTANTLY. BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16431926 ↗
• MalfunctionSep 3, 2020Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, BEFORE THE OPERATION, THE CATHETER WAS FLUSHED AND IT WAS LEAKING TRACHOMA ON THE JUNCTION OF SILICONE EX TENSION TUBE (BLUE) AND BIFURCATION (WHICH WAS NOT IMPLANTED). THE CATHETER WAS NOT REPAIRED. NORMAL SALINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10486837 ↗