Palindrome 8888145014Recalls & reported problems

Summary

The FDA's MAUDE database contains 312 adverse event reports that list this exact device (DI 10884521013148), received between Mar 29, 2017 and Mar 11, 2026 — classified as 15 injuries, 297 malfunctions.

The most frequently reported specific device problem is “Break” (163 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 25 most recent of 312 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT AS PER MEDICAL ORDERS, THE CENTRAL VENOUS CATHETER PORT WAS RUPTURED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 24575046 ↗
• MalfunctionDec 22, 2025Break; Separation Problem; Break; Separation Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE OF SUBCUTANEOUS PUNCTURE, IMMEDIATELY PRIOR TO INSERTING THE CATHETER INTO THE PATIENT, THE SYMMETRIC TIP CATHETER WAS BROKEN. THERE WAS NO IMPACT ON THE PATIENT'S VITAL SIGNS. NOTHING UNUSUAL WAS 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. NO EXCESSIVE FORCED USE ON THE DEVICE. AS A REMEDIAL ACTION, A NEW SET OF CONSUMABLES WAS DISASSEMBLED. THE PROCEDURE WAS ABLE TO PROCEED AND WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23868750 ↗
• MalfunctionNov 17, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER TIP WAS RUPTURED, AND THE HOSPITAL MONITORED AND REPORTED THE SAFETY INCIDENT AND ADVERSE REACTIONS. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568296 ↗
• MalfunctionNov 13, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER'S TIP GOT BROKEN. IT WAS ALSO STATED THAT A CRACK WAS OBSERVED AT THE LUER ADAPTER. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 23550295 ↗
• MalfunctionNov 13, 2025Break; Break

  ACCORDING TO THE REPORTER, THE CATHETER WAS USED FOR ONE MONTH AND WHILE ON THE DIALYSIS THE CONNECTOR WAS RUPTURED. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543259 ↗
• MalfunctionNov 12, 2025Break; Break

  ACCORDING TO THE REPORTER, AFTER CATHETERIZATION, THE PATIENT USED IT FOR LESS THAN 1 MONTH, AND DURING DIALYSIS TREATMENT, THE BLUE LUER ADAPTER/HEAD WAS CRACKED (BROKEN TIP). IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. IODOPHOR WAS TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE, AND THE RESULT WAS NORMAL. BLOOD VESSEL WAS THE OTHER PRODUCT BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS/DAMAGES WERE FOUND ON THE PRODUCT. THE TUBE/CATHETER WAS REPLACED AS A MEDICAL INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT TO ADDRESS THE ISSUE. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23539115 ↗
• MalfunctionNov 12, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING NORMAL USE, IT WAS OBSERVED THAT THE CATHETER HAD A CRACKED TIP (LUER ADPATER). IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533571 ↗
• MalfunctionNov 12, 2025Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO DIALYSIS, A CRACK WAS OBSERVED AT THE BLUE (VENOUS) LUER CONNECTOR, AND IT WAS ALSO STATED THAT THERE WAS A LEAK. THE CATHETER WAS REPAIRED. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533055 ↗
• MalfunctionNov 10, 2025Break; Break

  ACCORDING TO THE REPORTER, ON (B)(6) 2024, A LONG-TERM PALINDROME CHRONIC CATHETER WAS IMPLANTED IN THE PATIENT'S NECK FOR ONGOING DIALYSIS. THE PATIENT HAS BEEN UNDERGOING THRICE-WEEKLY SCHEDULED DIALYSIS SESSIONS SINCE THEN. ON THE DAY OF THE EVENT, AT 12:11, THE NURSE PREPARED THE CATHETER FOR USE BY DISINFECTING THE VENOUS END, ASPIRATING HEPARIN SOLUTION, AND CONNECTING A 10 ML SYRINGE TO TEST THE CATHETER'S FUNCTIONALITY. DURING THE PROCESS, A CRACK WAS OBSERVED AT THE THREADED CONNECTION OF THE VENOUS PORT (LUER ADAPTER). THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. BLOOD WAS DRAWN, AND NO LEAKAGE WAS DETECTED. THE COMPLICATION WAS IMMEDIATELY REPORTED TO THE PHYSICIAN, HEAD NURSE, AND DIRECTOR. AS AN INTERVENTION, A DOUBLE-LUMEN CATHETER WAS SUBSEQUENTLY CONNECTED, WITH LOW-FLOW DIALYSIS INITIATED. THROUGHOUT THE PROCEDURE, THE PATIENT AND CATHETER WERE CLOSELY MONITORED, WITH NO ABNORMALITIES OBSERVED. AS A REMEDIAL ACTION, THE PATIENT WAS INFORMED THAT THE VENOUS PORT INTERFACE WOULD BE SCHEDULED FOR REPLACEMENT. THE PROCEDURE WAS COMPLETED AFTER THE REMEDIAL ACTION. THE CATHETER WAS IN PLACE FOR 1 YE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512212 ↗
• MalfunctionOct 31, 2025Break; Break

  ACCORDING TO THE REPORTER, THE BLEEDING WAS OBSERVED AT THE ARTERIAL END OF THE CHRONIC CATHETER'S SPIRAL CONNECTOR. EXAMINATION REVEALED THAT THE SPIRAL CONNECTOR WAS CRACKED. THE CATHETER WAS NOT REPAIRED. THERE WAS A LEAK. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS DISCONTINUED AND REPLACED AS A REMEDIAL ACTION AND INTERVENTION. THE TREATMENT WAS CONTINUED AND COMPLETED WITHOUT AFFECTING THE PATIENT'S OVERALL MANAGEMENT. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438331 ↗
• MalfunctionOct 24, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING LINK PREPARATION, THERE WAS A CRACK AND LEAK OBSERVED IN THE BLUE (VENOUS) LUER ADAPTER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED. FLUSHING WAS DONE WITH NORMAL RESULTS. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. ALCOHOL-FREE IODOPHORS WERE THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. BY HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. PROVIDED IODOPHOR WAS TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. EXTRACORPOREAL BLOOD CIRCUIT FOR BLOOD PURIFICATION WAS THE OTHER PRODUCT BEING UTILIZED WITH THE DEVICE. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. AS A REMEDIAL ACTION, THE ARTERIAL END OF THE CONNECTION CATHETER WAS LINKED TO THE ARTERY, WHILE THE VENOUS END WAS CLAMPED. BLOOD WAS DRAWN BACK THROUGH THE PUNCTURE WITH AN INTRA-ARTERIOVENOUS NEEDLE TO ACHIEVE HEMOSTASIS, AND THE ENTIRE CATHETER WAS REPLACED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378359 ↗
• MalfunctionSep 16, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING HEMODIALYSIS, THE CATHETER WAS DAMAGED, AND BLOOD COULD ESCAPE FROM COMPRESSION. THE CATHETER WAS NOT REPAIRED. THERE WAS A LEAK AT THE JUNCTION OF THE EXTENSION TUBE (BLUE SIDE) AND BIFURCATE. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS/DAMAGES WERE FOUND ON THE PRODUCT. NO OTHER PRODUCTS ARE BEING UTILIZED WITH THE DEVICE. AS A REMEDIAL ACTION, THE CATHETER WAS REPLACED. THE PROCEDURE WAS CONTINUED AND COMPLETED AFTER THE REMEDIAL ACTION WAS PERFORMED. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. NO INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066329 ↗
• MalfunctionSep 3, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING NORMAL DISMANTLING, IT WAS FOUND THAT THE CATHETER'S BLUE (VENOUS) LUER ADAPTER CONNECTION SEAM HAD A CRACK. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THE METHOD UTILIZED TO TIGHTEN THE ADAPTERS WAS BY HAND. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE AND TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. AS A REMEDIAL ACTION, THE LUER ADAPTER WAS REPLACED. THE TREATMENT WAS COMPLETED. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE CATHETER WAS IN PLACE FOR 10 MONTHS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955054 ↗
• MalfunctionAug 26, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING NORMAL DISEMBARKATION, THE LUER CONNECTOR CONNECTION SEAM WAS FOUND TO HAVE A CRACKED AND DETACHED. THE CATHETER WAS REPAIRED. THERE WAS NO LEAK. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897798 ↗
• MalfunctionAug 21, 2025Break; Break

  ACCORDING TO THE REPORTER, ON (B)(6) 2024, A LONG-TERM PALINDROME CHRONIC CATHETER WAS IMPLANTED IN THE PATIENT'S INTERNAL JUGULAR VEIN. THE PATIENT HAS BEEN UNDERGOING THRICE-WEEKLY SCHEDULED HEMODIALYSIS SINCE THEN. ON THE DAY OF THE EVENT, AT 07:17, THE NURSE PERFORMED CATHETER ACCESS PROCEDURES, INCLUDING DISINFECTION OF THE VENOUS END, ASPIRATION OF HEPARIN SOLUTION, AND CONNECTION OF A 10 ML SYRINGE TO TEST CATHETER FUNCTIONALITY. A CRACK WAS OBSERVED AT THE THREADED CONNECTION OF THE VENOUS PORT. BLOOD ASPIRATION WAS PERFORMED WITHOUT ANY EVIDENCE OF LEAKAGE. THE INCIDENT WAS IMMEDIATELY REPORTED TO THE PHYSICIAN, HEAD NURSE, AND DIRECTOR. THE CLEANING AGENT(S) ARE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. NO EXCESSIVE FORCE WAS USED ON THE DEVICE. NO OTHER PRODUCTS ARE BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE INTERVENTION WAS A DOUBLE-LUMEN CATHETER THAT WAS THEN CONNECTED FOR LOW-FLOW HEMODIALYSIS, WITH CLOSE MONITORING OF T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860336 ↗
• MalfunctionAug 20, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT WAS ADMITTED FOR TREATMENT OF UREMIA. DURING DIALYSIS, A CRACK WAS OBSERVED IN THE THREADING OF THE CHRONIC CATHETER KIT VENOUS (BLUE) PORT/LUER ADAPTER, LEADING TO A TEMPORARY SUSPENSION OF DIALYSIS. A TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. THE INITIAL DISPOSITION WAS TO CONTACT THE SUPPLIER SITE TO INVESTIGATE THE CAUSE OF THE EVENT AND PREVENT RECURRENCE. AFTER REPLACING THE CATHETER WITH A NEW ONE AS THE INTERVENTION, THE TREATMENT WAS COMPLETED. THE PATIENT TREATMENT/CHECK-IN TIME WAS EXTENDED. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849514 ↗
• MalfunctionAug 13, 2025Break; Break

  ACCORDING TO THE REPORTER, ONE WEEK AFTER CATHETER PLACEMENT, THE CATHETER WAS OOZING BLOOD. THERE WAS A LEAK AT THE CATHETER SHAFT AND NOT AT THE JUNCTION OF THE BIFURCATE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. 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. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS NORMAL. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO DRESSING THE AREA. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THE PATIENT WAS NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE. THE CLEANING AGENT WAS SWITCHED OVER THE LIFE OF THE CATHETER. THE CLEANING AGENT WAS NEVER MIXED. THE SITE WAS NEVER USED WITH SEPSIDERM TO CLEAN THE CATHETER. THERE WAS NO PROTOCOL CHANGE FOR CLEANING AGENTS USED RECENTLY. THE PATIENT THEMSELVES WAS NOT USING ANY TYPE OF CLEANING AGENT OR ANTIBIOTIC ON THE CATHETER. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NO INSERTION SITE TREATED PRIOR TO PRODUCT PLACEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798563 ↗
• MalfunctionAug 8, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, IT WAS FOUND THAT THE CATHETER'S BLUE (VENOUS END) LUER ADAPTER HAD CRACKS. IT WAS ALSO STATED THAT THERE WAS A LEAK AT THE LUER ADAPTER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THE CLEANING AGENT USED ON THE DEVICE WAS IODOPHOR. TEGO WAS NOT UTILIZED. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE METHOD THAT WAS UTILIZED TO TIGHTEN THE ADAPTERS WAS BY HAND. THE CLEANING AGENT WAS NOT ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. AS A REMEDIAL ACTION, A NEW CATHETER WAS REPLACED. THE TREATMENT PROCEEDED AND WAS COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE EVENT. THE CATHETER HAS BEEN IN PLACE FOR 3 MONTHS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751758 ↗
• MalfunctionJul 29, 2025Break; Break

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT AT 12:55 PM, THE PATIENT WAS UNDERGOING HEMODIALYSIS ON MACHINE NO. 2. DURING THE PROCEDURE, THE MACHINE FREQUENTLY TRIGGERED AIR ALARMS. THE NURSE INVESTIGATED AND DISCOVERED A CRACK/HOLE AND LEAK AT THE VENOUS END (LUER ADAPTER) OF THE PATIENT'S RIGHT SUBCLAVIAN CENTRAL VENOUS CATHETER. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE PATIENT DID NOT EXPERIENCE AIR EMBOLISM DUE TO THE EVENT. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THE ISSUE WAS PROMPTLY REPORTED TO THE HEAD NURSE AND DEPARTMENT DIRECTOR, WHO CONFIRMED THAT THE FREQUENT AIR ALARMS FROM THE MACHINE WERE CAUSED BY AIR ENTERING THROUGH THE CRACK IN THE CATHETER PORT. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. AS A REMEDIAL ACTION, THE CATHETER WAS REPAIRED BY REPLACING THE CATHETER PORT WITH A NEW ONE. IT WAS STATED THAT THE DEPARTMENT DIRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649143 ↗
• MalfunctionJul 28, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING NORMAL USE, THE CATHETER HAD A CRACKED LUER CONNECTOR. THE CATHETER WAS NOT REPAIRED. THERE WAS A LEAK AND CRACK OBSERVED ON THE ARTERIAL (RED) LUER. TEGO WAS NOT UTILIZED. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS ARE BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCED USE ON THE DEVICE. FLUSHING WAS DONE WITH NORMAL RESULTS. ALCOHOL-FREE IODOPHORS WERE THE CLEANING AGENTS USED ON THE DEVICE AND ADAPTERS. THE CLEANING AGENT(S) ARE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. AS A REMEDIAL ACTION, A NEW CATHETER WAS REPLACED. THE PROCEDURE WAS CONTINUED AND COMPLETED AFTER THE REMEDIAL ACTION WAS PERFORMED. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. NO INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22639453 ↗
• MalfunctionJul 26, 2025Break; Break

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, THE PATIENT WAS ADMITTED TO THE HEMODIALYSIS UNIT FOR DIALYSIS. DURING THE PROCEDURE, A CRACK WAS OBSERVED AT THE VENOUS END OF THE HEMODIALYSIS CATHETER WHERE IT CONNECTS TO THE SYRINGE. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NO OTHER PRODUCTS ARE BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCED USE ON THE DEVICE. THE CLEANING AGENT(S) ARE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. NO INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22622385 ↗
• MalfunctionJul 22, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT WITH UREMIA REQUIRES DIALYSIS TREATMENT; TO ESTABLISH A VASCULAR ACCESS FOR HEMODIALYSIS, A DIALYSIS CATHETER WAS INSERTED. THE CONNECTION OF THE DIALYSIS CATHETER WAS CRACKED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WAS NO CONCOMITANT MEDICATION/DEVICE. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE CATHETER WAS REPAIRED BY REPLACING IT WITH A TITANIUM ALLOY CONNECTOR AS THE REMEDIAL ACTION DONE AND THE INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT PROCEEDED AND WAS COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565949 ↗
• MalfunctionJul 17, 2025Break; Break

  ACCORDING TO THE REPORTER, WHEN THE DIALYSIS TREATMENT WAS OFF THE MACHINE, THE BLUE (VENOUS) CONNECTOR WAS FOUND TO BE BROKEN. IT WAS MENTIONED THAT THE LUER WAS CRACKED AND HAD A LEAK. IT WAS STATED THAT THE CRACK IN THE CONNECTOR WAS OBSERVED PRIOR TO USE AND DURING FLUSHING. TEGO WAS NOT UTILIZED. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USE ON THE DEVICE. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538114 ↗
• MalfunctionJul 14, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, IT WAS FOUND THAT THE CATHETER HAD A CRACK AT THE BLUE (VENOUS) LUER CONNECTOR. IT WAS ALSO STATED THAT THERE WAS A LEAK AT THE LUER CONNECTOR. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THE CLEANING AGENT USED ON THE DEVICE WAS IODOPHOR. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO OTHER PRODUCT BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE METHOD THAT WAS UTILIZED TO TIGHTEN THE ADAPTERS WAS BY HAND. THE CATHETER WAS NOT REPLACED. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO REMEDIAL ACTION TAKEN. THE TREATMENT WAS COMPLETED. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE EVENT. THE CATHETER HAD BEEN IN PLACE FOR 2 MONTHS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22502863 ↗
• MalfunctionJul 7, 2025Break; Break

  ACCORDING TO THE REPORTER, AFTER THE END OF DIALYSIS, IT WAS OBSERVED THAT THE VENOUS LUER CONNECTOR WAS BROKEN (CRACKED) AND LEAKING DURING CLOSURE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. FLUSHING WAS DONE AND THE RESULT WAS NOT NORMAL. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. AS A REMEDIAL ACTION, THE CATHETER WAS REPAIRED BY REPLACEMENT OF THE TEMPORARY CATHETER CONNECTOR OF A DOMESTIC BRAND. THERE WAS NO REPAIR KIT USED. THE PROCEDURE WAS COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413804 ↗

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.