Palindrome 8888145058Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521013339), received between Dec 14, 2017 and Jan 23, 2025 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (6 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2025Break; Break

  ACCORDING TO THE REPORTER THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR CHRONIC KIDNEY DISEASE AND RECEIVED HEMODIALYSIS TREATMENT ACCORDING TO THE DOCTOR'S ADVICE ON (B)(6) 2025. DURING THE TREATMENT, CRACKS WERE FOUND AT THE HUB OF THE LONG-TERM CATHETER ARTERY END, AND A LITTLE BLEEDING OCCURRED AT THE HUB OF THE RIGHT INTERNAL JUGULAR LONG-TERM CATHETER ARTERY END, WHICH COULD NOT BE USED NORMALLY. IT WAS REPLACED WITH A NEW CENTRAL VENOUS CATHETER KIT FOR DIALYSIS TREATMENT, WHICH DID NOT CAUSE ADVERSE EFFECTS ON THE PATIENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21217932 ↗
• MalfunctionJul 18, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING FLUSHING BEFORE THE SURGERY, THE CATHETER HAD A CRACK AND LEAK ON THE SILICONE EXTENSION TUBE NEAR THE VENOUS/BLUE LUER ADAPTER. THE CATHETER WAS NOT REPAIRED. BESIDES THE REPORTED ISSUE, THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO LUER ADAPTER ISSUE. TEGO WAS NOT UTILIZED AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE AND NO CLEANING AGENT WAS USED ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. AS A REMEDIAL ACTION, THE DEVICE WAS REPLACED WITH ANOTHER SET OF PRODUCT ON THE SAME DAY OF THE EVENT.THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347599 ↗
• MalfunctionMar 29, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING FLUSHING, THE ARTERIAL SILICONE EXTENSION TUBE HAD WATER LEAKAGE (LEAKED LIQUID). THE LEAK WAS LOCATED ONLY ON THE ARTERIAL SILICONE EXTENSION NEAR THE CLAMP. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS TREATED WITH IODOPHOR DISINFECTION PRIOR TO PRODUCT PLACEMENT. THERE WAS NO EXCESSIVE FORCE WAS USED ON THE DEVICE. THE PRODUCT WAS REPLACED. THE TREATMENT WAS COMPLETED. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED DUE TO THE EVENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635456 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON (B)(6) 2022, THE PATIENT WENT TO THE HOSPITAL TO SEEK A SOLUTION. AFTER COMPREHENSIVE CONSIDERATION, THE DIRECTOR¿S TEAM DECIDED TO RE-IMPLANT THE CENTRAL VENOUS CATHETER KIT MODEL IN THE PATIENT'S RIGHT NECK. AFTER A WHILE, IT WAS OBSERVED THAT THE PATIENT'S PUNCTURE WOUND STILL HAD THE SAME PROBLEM, AND THE WOUND COULD NOT HEAL (THE INTERNAL ORIFICE DID NOT HEAL). TAKING INTO ACCOUNT THE POSSIBILITY OF INDIVIDUAL DIFFERENCES AMONG PATIENTS, THE SKIN TISSUE REJECTED POLYURETHANE CATHETERS. IN MID-NOVEMBER, THE HOSPITAL REMOVED THE PATIENT'S CATHETER, AND THE PATIENT'S WOUND HEALED A WEEK LATER. ACCORDING TO THE DIRECTOR'S KNOWLEDGE, THE PATIENT WAS LATER TRANSFERRED TO ANOTHER HOSPITAL FOR A NEW HIGH ARTERIOVENOUS FISTULA OPERATION, WHICH WAS ENOUGH TO CONTINUE DIALYSIS. IT WAS STATED THAT FOR THIS SPECIAL CASE, THE DIRECTOR POINTED OUT THAT THIS WAS DUE TO INDIVIDUAL DIFFERENCES IN PATIENTS, AND THERE WAS REJECTION OF THE CATHETER, WHICH HAS NOTHING TO DO WITH THE QUALITY OF THE IMPLANTED CATHETER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection

  MAUDE report 16250242 ↗
• MalfunctionJan 9, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, WHEN FLUSHING WAS DONE PRIOR TO INSERTION, IT WAS FOUND THAT THE ARTERIAL SILICONE EXTENSION TUBE WAS LEAKING. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LUER ADAPTER ISSUE. TEGO WAS NOT UTILIZED. POVIDONE IODINE DISINFECTION WAS THE CLEANING AGENT USED ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THE CLAMPS WERE MOVED TO A NEW LOCATION AFTER THE PROCEDURE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO DAMAGED TO THE DEVICE'S INTERNAL PACKAGING AND BOX. THE STERILE BARRIER STILL INTACT UPON RECEIPT. ANOTHER PRODUCT WAS REPLACED, SUCCESSFULLY USED AND CONTINUED/COMPLETED THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16121788 ↗
• InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER THE RIGHT INTERNAL JUGULAR VEIN CATHETER WAS PLACED FOR HALF A YEAR FOR HEMODIALYSIS, THE INTERNAL ORIFICE DID NOT HEAL (THE WOUND AT THE PUNCTURE POINT COULD NOT HEAL), RESULTING IN CATHETER-RELATED BLOODSTREAM INFECTION. AND SO ON (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH LEFT FEMORAL VEIN CATHETER WITH DACRON SLEEVE (CENTRAL VENOUS CATHETER KIT) IN THE HOSPITAL. IT WAS STATED THAT THE PATIENT HAD CATHETER REJECTION. IT WAS STATED THAT FOR THIS SPECIAL CASE, THE DIRECTOR POINTED OUT THAT THIS WAS DUE TO INDIVIDUAL DIFFERENCES IN PATIENTS, AND THERE WAS REJECTION OF THE CATHETER, WHICH HAS NOTHING TO DO WITH THE QUALITY OF THE IMPLANTED CATHETER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection

  MAUDE report 16069071 ↗
• MalfunctionDec 8, 2022Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS A CRACK AND A LEAK NOTED AT THE ARTERIAL EXTENSION TUBE NEAR THE BIFURCATE (JUNCTION) - PRODUCT QUALITY ISSUES. THERE WAS NO DAMAGE NOTED ON THE DEVICE PACKAGING. THE BOX OF THE DEVICE CAME IN WAS INTACT. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. NO CLEANING AGENT WAS USED ON THE DEVICE. FLUSHING WAS DONE PRIOR TO USE WITH RESULT OF WATER LEAKAGE. IT WAS SAID THAT THEY REPLACED THE PRODUCT WITH DIFFERENT LOT ON THE SAME DAY AS MEASURE TAKEN BY THE DOCTOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15946004 ↗
• InjuryAug 17, 2022Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE REGISTERED NURSE (RN) WAS CONNECTING THE PATIENT FOR IN-CENTER HEMODIALYSIS. BLOOD WAS NOTED "BACKED UP" IN THE VENOUS CATHETER BEFORE CONNECTION. THE DEVICE PULLED/FLUSHED WELL WITH NO CONCERN. THE PATIENT WAS CONNECTED TO A COMPETITOR'S MACHINE. BLOOD LEAK WAS NOTED SEEPING FROM VENOUS LINE ON CENTRAL VENOUS CATHETER (CVC). THE CATHETER WAS NOT REPAIRED, AND THERE WAS NO LUER ADAPTER ISSUE. THE DIALYSIS WAS PROMPTLY STOPPED AND VENOUS LINE WAS CLAMPED. AIR WAS NOTED IN VENOUS LINE AND BLUE HEMOSTAT WAS IMMEDIATELY CLAMPED ON MAIN CATHETER OF CVC. BLOOD WAS UNABLE TO BE RETURNED DUE TO CLAMPED CATHETER AND BLOOD SYSTEM WAS LOST. THERE WAS UNEXPECTED OR PROLONGED CARE, ADMISSION WAS REQUIRED FOR LINE REPLACEMENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15241313 ↗
• InjuryAug 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PATIENT ARRIVED FOR DIALYSIS. THE CATHETER WAS BEING FLUSHED WITH NORMAL SALINE PRIOR TO DIALYSIS CONNECTION AND THE VENOUS LUMEN EXPLODED AND SEVERED OFF. THE CATHETER WAS NOT REPAIRED, NO LEAK, AND NO LUER ADAPTER ISSUE. BROKEN LUMEN WAS IMMEDIATELY CLAMPED TO PREVENT AN AIR EMBOLISM. PATIENT MISSED DIALYSIS, LABS DRAWN DUE TO PATIENT'S INABILITY TO DIALYZE AND MEDICATION WAS GIVEN TO LOWER THE HIGH POTASSIUM. THERE WAS UNEXPECTED OR PROLONGED CARE, PATIENT WAS ADMITTED TO HOSPITAL FOR URGENT CVC (CENTRAL VENOUS CATHETER) EXCHANGE, THE CATHETER WAS REMOVED AND ANOTHER DIALYSIS CATHETER PLACED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15142988 ↗
• MalfunctionMay 7, 2022Break; Break

  ACCORDING TO THE REPORTER, THE PACKAGE WAS OPENED AND IN PREOPERATIVE PREPARATION, A CRACK AND LEAK WAS FOUND AT THE JUNCTION OF THE CATHETER'S BIFURCATE AND CATHETER SHAFT (Y-SHAPED) WHILE FLUSHING THE PRODUCT. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO DAMAGE FOUND ON THE DEVICE'S BOX AND PACKAGING. REPLACEMENT WAS DONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14317047 ↗
• InjuryNov 7, 2021Product Quality Problem; Product Quality Problem

  ACCORDING TO REPORTER, AFTER GETTING OFF THE MACHINE, THE PATIENT COMPLAINED OF CHILLS AND FEVER. THE BODY TEMPERATURE WAS MEASURED AT 37.3, THE BLOOD PRESSURE WAS 120/70MMHG, AND THEY CONSIDERED THE CATHETER BLOOD FLOW RELATED DISEASES. IT WAS REPORTED THAT THE FOLLOWING PRELIMINARY ACTION WAS DONE, BLOOD CULTURE, BLOOD ROUTINE, CRP(C-REACTIVE PROTEIN TEST), SAA (SERUM AMYLOID A), 0.9% SODIUM CHLORIDE 100ML, AMOXICILLIN AND CLAVULANATE POTASSIUM 1.2G FOR INJECTION, MICRO PUMP INJECTION FOR 4 HOURS AND THE TUBE WAS SEALED. THEN IT WAS FOUND THAT THE PATIENT CAUSED THE CATHETER INFECTION AND HAD NOTHING TO DO WITH THE CATHETER. IT WAS ALSO STATED THAT IT WAS VERIFIED ON THE TRACKER SALES RECORD THAT THIS MODEL WAS NOT SOLD AT THIS HOSPITAL. THE PATIENT INFECTION HAS BEEN CONTROLLED AND THE CURRENT DIALYSIS TREATMENT IS NORMAL.

  Patient problems: Chills; Fever; Unspecified Infection

  MAUDE report 12759123 ↗
• MalfunctionOct 19, 2020Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, IT WAS STATED THAT THE DOCTOR CANNOT HOLD THE CUFF INSIDE THE CATHETER BECAUSE THERE WAS A RUPTURE IN THE CLAMP. CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. NO CLEANING AGENT USED ON THE DEVICE SINCE THE EVENT HAPPENED PRIOR TO USE. THERE WERE NO DEFECTS/DAMAGES NOTED ON THE DEVICE, AND THERE WAS NO DAMAGE ON THE PACKAGING UPON RECEIPT. IT WAS SAID THAT THE DEVICE WAS REPLACED BY ANOTHER MANUFACTURER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10697735 ↗
• MalfunctionJun 28, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING POST DIALYSIS, A MINIMAL AMOUNT OF BLOOD OOZED FROM THE MIDDLE PART OF THE TRANSPARENT SILICONE HOSE (EXTENSION TUBE). BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO OTHER PRODUCT THAT WAS USED, TEGO WAS NOT UTILIZED, THERE WAS NO LUER CONNECTOR PROBLEM AND ENTOIODINE WAS THE CLEANING AGENT. IT WAS ALSO REPORTED THAT THE DEVICE WAS REMOVED AND REPAIRED. A NEW CATHETER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8743016 ↗
• MalfunctionDec 14, 2017Break; Break

  THE CUSTOMER STATED THE VENOUS LUER ADAPTER WAS LEAKING AND COULD NOT BE SEPARATED FROM THE CAP. A CRACK WAS OBSERVED AND THE CATHETER WAS REPAIRED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7118044 ↗
• MalfunctionDec 14, 2017Break; Break

  THE CUSTOMER STATED THE VENOUS LUER ADAPTER WAS LEAKING AND COULD NOT BE SEPARATED FROM THE CAP. A CRACK WAS OBSERVED AND THE CATHETER WAS REPAIRED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7118024 ↗

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.