Palindrome 8888145059Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521013346), received between Nov 8, 2021 and Mar 13, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K111372); they may or may not involve this specific model.

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 18, 2026.

Recalls naming this device

1. Jun 8, 2022Class IOpen, Classified

   There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

   Z-1316-2022 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionMar 13, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, WHEN THE CATHETER WAS FULLY FLUSHED, IT WAS DIFFICULT FOR THE BLUE HEART STENT TO ENTER (THE BUTTERFLY WING), AND AFTER BARELY ENTERING, IT COULD NOT BE PULLED OUT. IT WAS ALSO MENTIONED THAT THE GUIDEWIRE COULD NOT PASS THROUGH THE BUTTERFLY WING AT THE ARTERY END. AFTER WETTING AND FORCING IT THROUGH, THE GUIDE WIRE WAS KINKED, ALSO GOT STUCK, COULD NOT BE PULLED OUT, AND THE GUIDE WIRE HAD TO BE CUT OFF. TO COMPLETE THE CATHETERIZATION, A NEW SET OF CATHETERS WAS DISASSEMBLED, THE ORIGINAL SET OF CATHETERS WAS SCRAPPED, AND A NEW PRODUCT WAS USED TO REPLACE THEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16531819 ↗
• InjuryNov 8, 2021Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, THE PATIENT DEVELOPED CHILLS AND FEVER 3 HOURS AFTER THE DIALYSIS. THE BODY TEMPERATURE WAS 38.6 (DEGREES CELSIUS) AND BLOOD PRESSURE WAS 105/65MMHG, AND THE INFECTION RELATED TO CATHETER BLOOD FLOW WAS CONSIDERED. IT WAS SAID THAT DEXAMETHASONE 5MG WAS GIVEN INTRAVENOUSLY, RETURN OF BLOOD TO THE MACHINE, DRAW BLOOD CULTURE, BLOOD ROUTINE, CRP (C REACTIVE PROTEIN), SAA (SERUM AMYLOID A) WERE DONE AND 0.9% SODIUM CHLORIDE 100ML PLUS INJECTION WITH CEPHALOSPORIN SODIUM 1G MICROPUMP WAS INJECTED FOR 4HOURS AND THE TUBE WAS SEALED. IT WAS THEN REPORTED THAT THE PATIENT CAUSED THE CATHETER INFECTION WHICH HAD NOTHING TO DO WITH THE CATHETER AND THEY WERE NOT RESPONSIBLE FOR IT. THE PATIENT¿S INFECTION HAD BEEN CONTROLLED AND THE CURRENT DIALYSIS TREATMENT WAS NORMAL.

  Patient problems: Chills; Fever; Unspecified Infection

  MAUDE report 12769256 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111372. One submission often covers many models, so check the product and lot details in each record.

• Z-2632-2023 · Aug 22, 2023 · Open, Classified
  Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
• Z-1320-2022 · Jun 8, 2022 · Open, Classified
  Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.