Palindrome 8888145041PRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10884521158047), received between Jul 21, 2017 and Nov 26, 2025 — classified as 2 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (8 reports).

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

48 other recalls cover devices cleared under the same FDA submission (K123196); 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-1312-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, UPON DISCONNECTION, A BLOOD STAIN WAS OBSERVED ON THE STERILE DRAPE, AND BLOOD WAS NOTED AROUND THE VENOUS CLAMP OF THE DIALYSIS CATHETER. AFTER CLEANING THE CLAMP, NOTHING ABNORMAL WAS VISIBLE. FLUSHING OF THE VENOUS BRANCH SHOWED NO ISSUES EITHER. HOWEVER, DURING A PRESSURIZED FLUSH OF THE VENOUS BRANCH WITH THE CLAMP CLOSED AND SALINE SYRINGE INJECTED UNDER PRESSURE, A LEAK WAS IMMEDIATELY OBSERVED AT THE BRANCH LEVEL. THE CATHETER WAS NOT REPAIRED. THERE WAS A LEAK AT THE CATHETER SHAFT. THERE WAS NO LEAKING AT THE JUNCTION OF THE BIFURCATE AND CATHETER. ONLY STERILE SALINE (PHYSIOLOGICAL SERUM) WAS USED. NO CHEMICAL CLEANING AGENTS WERE APPLIED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23653708 ↗
• MalfunctionJul 1, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, DURING THE INSTALLATION OF A TUNNELED CATHETER, THE RIGHT FEMORAL CATHETER DID NOT PROVIDE FLOW, REQUIRING IT TO BE REINSTALLED. THE CATHETER WAS NOT REPAIRED, AND THERE WAS NO LEAK. A TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. THE PRODUCT WAS REPLACED. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT PERMANENT IMPAIRMENT OF FUNCTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379332 ↗
• MalfunctionJul 1, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, DURING THE INSTALLATION OF A TUNNELED CATHETER, THE RIGHT FEMORAL CATHETER DID NOT PROVIDE FLOW, REQUIRING IT TO BE REINSTALLED. THE CATHETER WAS NOT REPAIRED, AND THERE WAS NO LEAK. A TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. THE PRODUCT WAS REPLACED. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT PERMANENT IMPAIRMENT OF FUNCTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22378770 ↗
• MalfunctionMay 31, 2025Break; Break

  ACCORDING TO THE REPORTER, WHILE THE PATIENT WAS IN THE OUTPATIENT DIALYSIS CENTER, AND IT WAS UNKNOWN WHETHER IT OCCURRED DURING CONNECTION OR DISCONNECTION, A FRACTURE OR CRACK OF THE THREAD ON THE BLUE (VENOUS) ADAPTER/CONNECTION PART WAS SEEN. THERE WERE NO INDICATIONS OF AN ACUTE IMPAIRMENT OF THE PATIENT'S CONDITION. NO FLUID LEAKAGE WAS OBSERVED AT THE DEFECT WHEN THE CLAMP OF THE LEG WAS CLOSED, AND VISUALLY, NO MAJOR AIR INGRESS WAS NOTED. THE ADAPTERS WERE TIGHTENED BY HAND. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. THERE WAS NO TEGO ADAPTER ON THE CATHETER WHEN THE DOCTOR RECEIVED THE PATIENT. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. ON THE SAME DAY AFTER THE INITIAL OBSERVATION, THE PATIENT WAS PRESENTED TO THEM, AND THEY REPAIRED THE CATHETER AS AN INTERVENTION BY REPLACING THE VENOUS ADAPTER (THE ATTACHMENT/CONNECTOR PIECE ON THE VENOUS SNAIL) USING THE COMPANY'S ACUTE AND CHRONIC CATHETER REPAIR KIT WITH A DIFFERENT LOT AND PRODUCT ID (IDENTIFIER). THE CATHETER WAS NOT REMOVED. IT WAS UNLIKELY THAT ANY OF THE PATIENT'S CONDITIONS CONTRIBUTED TO THE RUPTURE OF THE VENOUS CONNECTOR. THERE WAS NO BLOOD LOSS. NO BLOOD TRANSFUSION WAS REQUIRED.

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

  MAUDE report 22120338 ↗
• MalfunctionMay 12, 2025Break; Break

  ACCORDING TO THE REPORTER WHEN CLEANING THE VENOUS LUMEN, THERE WAS A CREAKING NOISE AND FELT THAT THE TEGO WAS LOOSE. THE HCP (HEALTHCARE PROFESSIONAL) TRIED TO TIGHTEN THE TEGO WHEN THE LUER LOCK (END OF LUMEN) COMPLETELY BROKE OFF. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22000289 ↗
• MalfunctionMay 1, 2025Break; Break

  ACCORDING TO THE REPORTER, ON COMMENCEMENT OF TREATMENT, WHEN THE VENOUS LUMEN WAS BEING CLEANED PRIOR TO ACCESSING THE LUMEN AND COMMENCING HEMODIALYSIS, THE USER NOTICED A CREAKING NOISE AND FELT THAT THE TEGO CAP WAS LOOSE. WHEN THE USER TRIED TO TIGHTEN THE TEGO CAP, THE VENOUS LUMEN COMPLETELY BROKE OFF. DUE TO THE ABOVE POINT, DIALYSIS HAD TO BE DELAYED. CONSEQUENTLY, THE CLINICIAN TRIED TO TAKE BLOOD FROM THE ARTERIAL LUMEN TO ASSESS THE PATIENT. DURING THE WITHDRAWAL OF BLOOD FROM THE ARTERIAL LUMEN, A LEAK WAS NOTED AT THE ARTERIAL LUMEN LUER CONNECTOR. THE CATHETER HAD BEEN INSERTED ON (B)(6) 2025, AND BECAUSE OF THE INCIDENT, THE PRODUCT WAS EXPLANTED AND REPLACED WITH ANOTHER CATHETER. THE PATIENT WAS NOT ABLE TO RECEIVE TREATMENT SCHEDULED ON THE DAY OF THE INCIDENT. PREVIOUS TREATMENT WAS (B)(6) 2025, AND SUBSEQUENT TREATMENT AFTER CATHETER REPLACEMENT WAS (B)(6) 2025. A BLOOD POTASSIUM LEVEL WAS TAKEN AT THE TIME OF THE INCIDENT AND RETURNED A RESULT OF 5.3 MMOL/L. THE PATIENT WAS GIVEN CALCIUM RESONIUM ORALLY TO PREVENT HYPERKALEMIA UNTIL THE NEXT DIALYSIS TREATMENT. NO OTHER CLINICAL INTERVENTIONS WERE DONE. THERE WAS NO BLOOD LOSS. THE CATHETER WAS LOCKED BETWEEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21947397 ↗
• MalfunctionNov 15, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, ON (B)(6) 2024, THE PROCEDURE WAS HELD. TWO CATHETERS WERE DYSFUNCTIONAL DUE TO CLOT FORMATION. IT WAS ALSO STATED THAT THE PATIENT WITH CATHETERS COMMONLY HAD FIBRIN SHEATH AND CLOTS THAT FORMED AROUND THE TIP LEADING TO POOR FLOW RATES AND HIGHER PRESSURE. AS A REMEDIAL ACTION, CATHETER WAS DYSFUNCTION DESPITE TPA (TISSUE PLASMINOGEN ACTIVATOR) INSTILLED. CXR (CHEST X-RAY) WAS DONE AND SHOWED THE CATHETER TO BE SHORT. THE PROCEDURE DID NOT CONTINUE AND WAS NOT COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696059 ↗
• MalfunctionOct 8, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING NORMAL USE, THERE WERE CRACKS IN THE BACK END (LUER ADAPTER) OF THE CATHETER. THERE WAS NO LEAK. ALCOHOL WAS THE CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. A REPAIR KIT WAS USED TO RESTORE THE CATHETER TO WORKING CONDITION, AND THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396371 ↗
• MalfunctionOct 3, 2024Migration; Migration

  ACCORDING TO THE REPORTER, ONE MONTH AFTER THE CATHETER WAS INSERTED, THE CATHETER HAD DISPLACED AND FALLEN OUT. ON (B)(6) 2024 WAS THE DATE OF THE FIRST STUDY PROCEDURE. STUDY EXIT DATE WAS ON (B)(6) 2024. THE DEVICE DEFICIENCY COULD NOT LEAD TO A SERIOUS ADVERSE DEVICE EFFECT (SADE) IF SUITABLE ACTION HAD NOT BEEN TAKEN, INTERVENTION HAD NOT BEEN MADE, OR CIRCUMSTANCES HAD BEEN LESS FORTUNATE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20358403 ↗
• InjuryAug 8, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER HAD A SPLIT WHERE THE VENOUS HUB WAS PUSHED INTO THE SILICONE TUBING. IT WAS STATED THAT IT WAS RIGHT ON THE EDGE OF WHERE THE HUB STOPPED. IT WAS DISCOVERED DURING FLUSHING WITH A 20-ML SYRINGE, WITH FLUID PUSHING OUT OF THE SPLIT AND HITTING THE CEILING. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. CHLORHEXIDINE 2% IN 70% ALCOHOL WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. FLUSHING WAS DONE PRIOR TO USE, AND SALINE WAS SQUIRTED FROM A CRACK IN THE VENOUS TUBING. CITRAVALVE WAS THE OTHER PRODUCT BEING UTILIZED WITH THE DEVICE. THERE WAS A CRACK ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. THERE WAS NO BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT REQUIRED. THE PATIENT'S BLOOD WAS SAFELY RETURNED. THE TREATMENT PROCEEDED AND WAS COMPLETED. RECONNECTING THE SILICONE TUBING IN THE VENOUS HUB AND PLACING A TEMPORARY TAPE TO HOLD WHILE THE PATIENT WAS ON HEMODIALYSIS TREATMENT WAS THE INTERVENTION REQUIRED AS A RESULT OF THE EVENT. REPAIRED THE FAULTY SILICONE TUBING AND VENOUS HUB BY USING REPAIR KIT AND SUBSEQUENT EXCHANGE. THIS WAS THE REMEDIAL ACTION DONE TO ADDRESS THE ISSUE. THERE WAS NO REPOR

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

  MAUDE report 19944424 ↗
• MalfunctionJun 10, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING ITS FIRST HEMODIALYSIS USE OF THE RIGHT INTERNAL JUGULAR VEIN (RIJ) CATHETER, THERE WAS A SMALL AMOUNT OF BLOOD COMING FROM THE VENOUS CLEAR TUBING BELOW THE HUB. THIS BLOOD WAS WIPED AWAY, AND NO FAULT WAS ABLE TO BE SEEN; HOWEVER, 2.5 HOURS INTO HEMODIALYSIS, THERE WAS BLOOD LEAK ONTO THE PATIENT¿S SHIRT. CHLORHEXIDINE 70%, AND 20% ALCOHOL WITH RED TINT WERE THE CLEANING AGENTS USED ON THE DEVICE. THE CLAMP HAD BEEN PLACED BETWEEN THE HUB AND FAULT, AND THEY WERE HOPEFUL THIS WOULD PREVENT ANY FURTHER BLEEDING AT THE MOMENT AND THE TREATMENT WAS COMPLETED. THE PRODUCT WAS REMOVED TO RESOLVE THE ISSUE. THE EXTENSION TUBE WAS NOT REPAIRED. NO EXCHANGE NECESSARY AS PATIENT CEASED DIALYSIS. THERE WERE 15 MILLILITERS OF BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 19499460 ↗
• MalfunctionJan 4, 2024Migration; Migration

  ACCORDING TO THE REPORTER, THE PATIENT HAD ACCIDENTALLY PULLED THE LINE WHILE AT HOME, AND THERE WAS SOME LIGHT BLEEDING OR OOZING BLOOD. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO THE EVENT. FLUSHING WAS NOT DONE PRIOR TO THE EVENT. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT DURING THE EVENT. NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE DURING THE EVENT. THE STANDARD CLEANING OF THE DIALYSIS CATHETER IN AND OUT OF THE UNIT WAS DONE WITH GREEN CLINELL DEVICE WIPES, 2% CHLORHEXIDINE, 70% ALCOHOL, AND COMPETITOR'S CHLORAPREP ON DRESSING CHANGE DAYS. THE LINE WAS DRESSED WITH COMPETITORS' TEGADERM CHG (CHLORHEXIDINE GLUCONATE) DRESSINGS. THE PATIENT WAS ASKED TO COME IN SO THAT THEY COULD CHECK AND WAS GIVEN THE INSTRUCTION TO PRESS ON THE LINE WITH A STERILE SWAB AND CALL AN AMBULANCE IF THERE WAS CONTINUED BLEEDING OR IF THE LINE FELL OUT. THE PATIENT CAME INTO THE UNIT, AND WHEN EXAMINED BY THE NURSES IN THE DIALYSIS UNIT, BOTH SUTURES OR STITCHES WERE IN PLACE, AND THERE WAS NO REDNESS OR ANY SIGN OF INFECTION. THE LINE INSERTION SITE WAS VERY TENDER, AND THE ORIGINAL DRESSING HAD A BLOOD STAIN BUT WAS NOT BLEEDING. THE LINE WAS REDRESSED (DRESSING CHANGE),

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18446778 ↗
• MalfunctionDec 21, 2023Migration; Migration

  ACCORDING TO THE REPORTER, WHEN NURSES WENT TO USE THE LINE FOR DIALYSIS AS USUAL, THEY NOTED THAT THE CUFF WAS OUT AND THE LINE WAS DISLODGED. THE PATIENT STATED THAT THE LINE MIGHT HAVE DISLODGED WHILE SLEEPING. WHEN THE PATIENT WOKE UP, THE PATIENT FELT SOMETHING ON THE ABDOMEN AND REALIZED IT WAS THE LINE. THE LINE THEN FELL OUT COMPLETELY WHEN THE PATIENT STOOD UP AND WENT TO CHANGE THE PAJAMA TOP WHILE AT HOME. NO OTHER DEFECTS OR DAMAGE WERE FOUND ON THE PRODUCT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. THE STANDARD CLEANING OF THE DIALYSIS CATHETER IN AND OUT OF THE UNIT WAS DONE WITH GREEN CLINELL DEVICE WIPES, 2% CHLORHEXIDINE, 70% ALCOHOL, AND COMPETITOR'S CHLORAPREP ON DRESSING CHANGE DAYS. THE LINE WAS DRESSED WITH COMPETITORS' TEGADERM CHG (CHLORHEXIDINE GLUCONATE) DRESSINGS. THE PATIENT'S USUAL DIALYSIS UNIT WAS AT ANOTHER HOSPITAL. THE PATIENT APPLIED PRESSURE TO THE SITE AND WAS TAKEN TO THE MAIN UNIT IN THE HOSPITAL FOR FURTHER ASSESSMENT. THE PATIENT WAS ASSESSED ON THE SAME DAY; THE LINE SITE WAS NOT ACTIVELY BLEEDING AND THE BLOOD WAS SAFE, SO THE PATIENT WAS ALLOWED TO GO HOME THE NEXT DAY WITH RECHECKED BLOOD AT THE DIALYSIS UNIT. THE PRODUCT WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18375458 ↗
• MalfunctionOct 13, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, A DEFECT WAS NOTED IN THE PATIENT¿S HEMODIALYSIS CENTRAL LINE WHEREIN THERE WAS A MOVEMENT OF BLOOD BETWEEN THE TWO LUMENS OF THIS PATIENT¿S HEMODIALYSIS CATHETER. THE TWO SYSTEMS SHOULD BE SEPARATED FROM ONE ANOTHER. IT WAS SAID THAT THE PATIENT EXPERIENCED SIGNIFICANT BLOOD RECIRCULATION DURING DIALYSIS. THE RESULT WAS BEING A REDUCTION IN THE EFFICIENCY OF THE DIALYSIS TREATMENT. THERE WAS NO INVASIVE PROCEDURE DONE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15600925 ↗
• MalfunctionAug 30, 2022Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THERE WAS A HOLE IN THE VENOUS TUBE OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324390 ↗
• MalfunctionAug 26, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PRODUCT WAS A KNOWN RECALLED PRODUCT BUT PER REGIONALLY COMMUNICATED EMAIL FROM THE SENIOR CLINICAL RISK ADVISOR FROM ALBERTA HEALTH SERVICES, THE DEVICE COULD BE USED UNDER THE DISCRETION OF THE PHYSICIAN. IT WAS DECIDED THAT IT WAS THE APPROPRIATE CATHETER TO BE USED FOR HEMODIALYSIS (HD) CENTRAL LINE INSERTION AND SO TO ENSURE FUNCTIONALITY OF THE MEDICAL DEVICE PROPER DIRECTION WAS FOLLOWED. IT WAS STATED THAT THE PHYSICIAN, TECHNOLOGIST AND NURSE TRIPLE CHECKED THE DEVICE. IT WAS NOTED THAT UPON INFUSION OF SALINE INTO THE VENOUS PORT, REFLUX OF FLUID WAS COMING BACK INTO THE OPPOSITE ARTERIAL PORT. THIS WAS OBSERVED THROUGH THE CLEAR PORTION OF THE CATHETER, DISTAL TO THE ENDCAPS. THE CATHETER WAS REMOVED FROM THE STERILE FIELD. A SECOND CATHETER WAS OPENED, AND TRIPLE CHECKED AND WAS FOUND TO BE IN PROPER OPERATION. IT WAS DOCUMENTED IN THE CHART THAT THE CATHETER WAS VERIFIED SAFE TO USE BY THE RADIOLOGIST. 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 15307523 ↗
• MalfunctionAug 11, 2022Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING TUNNELED CATHETER PLACEMENT, THE GUIDE WIRE KINKED, WITH THE IMPOSSIBILITY OF EITHER PUSHING IT FURTHER OR REMOVING IT, REQUIRING THE NEEDLE TO BE REMOVED WITH THE GUIDE WIRE STUCK IN PLACE/STUCK AT THE INSIDE AS IF SHEARED AT THE EXIT OF THE NEEDLE (REQUIRING IMMEDIATE WITHDRAWAL OF THE NEEDLE WITH THE GUIDE WIRE). OBLIGATION TO REMOVE THE NEEDLE WHERE THE GUIDE WIRE LOCATED, OBLIGATION FOR MULTIPLE PUNCTURE OF THE INTERNAL JUGULAR VEIN WITH RISK OF BLEEDING ON ANTIPLATELET AGENTS. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15210156 ↗
• MalfunctionApr 11, 2022Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING TREATMENT ON THE (B)(6) 2022, EXTENSIONS WERE EXAMINED BY THE VASCULAR ACCESS NURSE AND NO LEAK WAS FOUND, SO THE PATIENT WAS COMMENCED ON DIALYSIS. WITHIN 20 MINUTES OF COMMENCING TREATMENT, A PIN PRICK LEAK OF 1-3MLS WAS NOTED IN THE MIDDLE OF ARTERIAL (RED) EXTENSION TUBE, RENAL REGISTRAR AND VASCULAR ACCESS NURSE NOTIFIED AND THE TREATMENT WAS CEASED. NO ADDITIONAL MEDICAL TREATMENT REQUIRED AS A RESULT OF THE LEAK, THE PATIENT REFUSED REVIEW, REMOVAL OF LEAKING CATHETER AND INSERTION OF A NEW CATHETER WITH SAME PRODUCT ID (IDENTIFIER), SAME LOT INTO THE SAME SITE DUE TO LIMITED OPTIONS FOR THIS PATIENT OCCURRED ON THE (B)(6) 2022, THIS INVOLVED A GENERAL ANESTHETIC AND AN OVERNIGHT STAY IN HOSPITAL, USUAL TREATMENT REGIME WAS COMMENCED. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS DONE AND NOTHING NOTED. THE CLAMPS WERE ROUTINELY MOVED FOR CLEANING AND DRESSING AND IT WAS NOT A PROTOCOL. THE CATHETER WAS NOT REPAIRED, NO LUER ADAPTER ISSUE, ALCOHOLIC CHLORHEXIDINE WAS THE CLEANING AGENT USED ON DEVICE, THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA, AND THE INSERTION SITE WAS TREATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14074245 ↗
• MalfunctionApr 10, 2022Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, A LEAK (1 TO 3 ML) WAS NOTED ON THE VENOUS EXTENSION TUBE THAT HAD BEEN PREVIOUSLY REPAIRED (IT HAD BEEN REPAIRED LAST 2022). THE LEAK WAS BELOW THE PREVIOUS REPAIR, CLOSER TO THE HUB. CHLORHEXIDINE AND ALCOHOL 2% AND 70% WAS THE CLEANING AGENTS USED ON THE DEVICE. TEGO WAS UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED WITH ALCOHOLIC CHLORHEXIDINE PRIOR TO PRODUCT PLACEMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND FLUSHING WAS DONE AND NOTHING WAS NOTED. ASIDE FROM THE TEGO (CODAN BC 1000N), STANDARD BLOODLINES AND SYRINGES WERE UTILIZED WITH THE DEVICE. THERE WERE NO VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. ALTHOUGH NOT A PROTOCOL, THE CLAMPS WERE ROUTINELY MOVED FOR CLEANING AND DRESSING. THE TREATMENT WAS STOPPED ONE HOUR BEFORE THE PRESCRIBED TIME. BLOOD TESTS WERE TAKEN AND THE RENAL REGISTRAR AND VASCULAR ACCESS NURSE WERE NOTIFIED. BLOOD TRANSFUSION WAS NOT REQUIRED. ONE TREATMENT WAS MISSED WHILE WAITING FOR THE CATHETER TO BE REPLACED. THE LEAKING CATHETER WAS NO LONGER REPAIRED BUT WAS REMOVED AND WAS REPLACED BY A NEW ONE ON (B)(6) 2022 WHICH REQUIRED GENE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14069401 ↗
• MalfunctionApr 7, 2022Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING POST-DIALYSIS AND WHEN FULL TREATMENT WAS COMPLETED, SMALL PIN PRICK BLOOD LEAK OF BETWEEN 1-3ML WAS NOTED IN THE MIDDLE OF ARTERIAL (RED) EXTENSION TUBE. NO ADDITIONAL MEDICAL TREATMENT REQUIRED AS A RESULT OF THE LEAK, AND THE PATIENT REFUSED REVIEW. THE REMOVAL OF THE LEAKING CATHETER AND INSERTION OF A NEW CATHETER WITH SAME PRODUCT ID (IDENTIFIER), SAME LOT INTO THE SAME SITE DUE TO LIMITED OPTIONS FOR THIS PATIENT OCCURRED ON THE (B)(6) 2022. THIS INVOLVED GENERAL ANESTHETIC AND OVERNIGHT STAY IN HOSPITAL, USUAL TREATMENT REGIME WAS COMMENCED. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS DONE AND NOTHING NOTED. THE CLAMPS WERE ROUTINELY MOVED FOR CLEANING AND DRESSING AND IT WAS NOT A PROTOCOL. THE CATHETER WAS NOT REPAIRED, NO LUER ADAPTER ISSUE, ALCOHOLIC CHLORHEXIDINE WAS THE CLEANING AGENT USED ON DEVICE, THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA, AND THE INSERTION SITE WAS TREATED WITH BETADINE. STANDARD BLOOD LINES, SYRINGE, AND A COMPETITOR¿S TEGO TYPE DEVICE WERE UTILIZED. BLOOD TRANSFUSION WAS NOT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14048794 ↗
• MalfunctionApr 7, 2022Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING COMPLETION OF DIALYSIS, WHEN THE EXTRACORPOREAL CIRCUIT WAS GIVEN BACK TO THE PATIENT, A LEAK OF LESS THAN ONE ML WAS NOTED FROM THE VENOUS LUMEN/EXTENSION WITHIN 0.5CM FROM THE END OF THE COLORED LUER. THE RENAL VASCULAR ACCESS NURSE REVIEWED THE CATHETER AND FELT IT COULD BE REPAIRED. IT WAS SAID THAT THE TREATMENT WILL BE CONTINUED UNTIL THE REPAIR KIT COULD BE ORDERED AND RECEIVED. NO DEFECTS/DAMAGES WERE FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED AS IT WAS DIFFICULT TO SEE (ONLY TINY BLOOD LEAK WAS VISIBLE). ALCOHOLIC CHLORHEXIDINE WAS THE CLEANING AGENT USED ON THE DEVICE. NO OINTMENTS WERE USED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS CLEANED WITH ALCOHOLIC CHLORHEXIDINE. IT WAS SAID THAT IT WAS NOT A PROTOCOL TO MOVE THE CLAMPS TO A NEW LOCATION AFTER EACH TREATMENT BUT THEY WERE ROUTINELY MOVED FOR CLEANING AND DRESSINGS ETC.. CODAN BC1000N, STANDARD BLOODLINES AND SYRINGES WERE BEING UTILIZED WITH THE DEVICE. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPAIRED ON (B)(6) 2022 AND THE TREATMENT WAS CONTINUED UNTIL (B)(6) 2022 WHEN A FURT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14044961 ↗
• MalfunctionDec 13, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  ACCORDING TO THE REPORTER, DURING VISUAL INSPECTION, THE WOUND AT THE EXIT SITE DID NOT CLOSE UP EVEN THE CATHETER PLACEMENT WAS DONE FOUR WEEKS AGO. IT WAS SAID THAT THE CATHETER CAN NOT BE HELD IN PLACE BUT IT DID NOT COMPLETELY MOVE OUT OF THE PATIENT. IT WAS LOOSE BECAUSE THE EXIT SITE DID NOT HEAL, SO TECHNICALLY THE CATHETER CAN BE MOVED OUT/AROUND OF ITS INTENDED POSITION. IT WAS ALSO SAID THAT THE STITCHES HELD BUT WERE REMOVED AT 4TH WEEK AFTER THE CATHETER PLACEMENT BASED ON HOSPITAL PRACTICE. THERE WERE NO ISSUES WITH THE SUTURE WINGS AND NO INFECTION IN THE WOUND AT THE EXIT SITE. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. AQUEOUS BASED POVIDONE IODINE WAS THE CLEANING AGENT USED ON THE DEVICE. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION WAS REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE DOCTOR NEEDED TO REPLACE IT WITH ANOTHER CATHETER (SPLIT CATHETER) FROM ANOTHER MANUFACTURER WHICH RESOLVED THE ISSUE AND AFTER THE REPLACEMENT, THE PATIENT HAD A DIALYSIS TREATMENT COMPLETED. IT WAS SAID THAT THE PATIENT WAS DISCHARG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12984260 ↗
• MalfunctionSep 15, 2021Product Quality Problem; Obstruction of Flow; Product Quality Problem; Obstruction of Flow

  ACCORDING TO THE REPORTER, ON THE BACK TABLE PRIOR TO INSERTION, ONE OF THE STYLETS WOULD NOT GO DOWN THE ARTERIAL LUMEN SIDE. AFTER MULTIPLE ATTEMPTS, THE DOCTOR WANTED TO SEE IF IT WAS CATHETER ISSUE SO THE HUB WAS CUT AND THE DOCTOR TRIED TO GET THE STYLET DOWN BUT HAD NO LUCK. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE DEVICE WAS FLUSHED WITH HEPARINIZED SALINE WITH NORMAL RESULT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT AND THERE WAS NO OCCLUSION. THE STYLET THAT WAS USED WAS THE ONE INCLUDED IN THE KIT. THERE WAS NO BLOOD LOSS AND THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THEY USED OR OPENED ANOTHER CATHETER TO RESOLVE THE ISSUE WHICH WAS PLACED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12478492 ↗
• MalfunctionMar 26, 2021Migration or Expulsion of Device; Defective Component; Migration or Expulsion of Device; Defective Component

  ACCORDING TO THE REPORTER, SIX MONTHS AFTER THE CATHETER WAS INSERTED TO THE PATIENT, A MINOR/SLIGHT CURVE WAS NOTED, BUT NOTHING UNUSUAL. AFTER A WEEK, THE CATHETER WAS TWISTED AND CURVE (DISTORTION). SEPARATION INTERNALLY OF LUMENS WAS EVIDENT AND THE CUFF WAS STARTING TO EXTRUDE. AT THE TIME OF THE INSERTION OF THE CATHETER, POVIDINE IODINE WAS USED. FOR THE PATIENTS ONGOING DIALYSIS TREATMENT CATHETER CARE, THE ROUTINE USED BY THE DIALYSIS STAFF FOR THE PATIENT AND CATHETER WAS THAT THEY USED BACTROBAN OINTMENT (MUPIROCIN) AND IV 3000 DRESSING CHANGED THREE TIMES PER WEEK (USUAL PROTOCOL WAS BIOPATCH WEEKLY, BUT IT CAUSED A REACTION IN THIS PATIENT). THEY ALSO USED SMALL TEGADERM IN ARMPIT AREA. THEY USED GRIPLOCK FOR SECUREMENT, CHANGED WEEKLY. THEY ALSO USED Q-CYTES ON THE PATIENT AND 1000 UNITS/ML OF HEPARIN LOCK WAS GIVEN. THE PATIENT HAD KNOWN SENSITIVITIES TO SOLUTIONS AND DRESSINGS, HENCE WHY THE PATIENT WAS HAVING A DIFFERENT REGIMEN COMPARED TO THE STANDARD PROTOCOL FOR CVC (CENTRAL VENOUS CATHETER) CARE IN THE UNIT. THE PATIENT WAS NOT DIALYZED ANYWHERE ELSE. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, TEGO WAS UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. NO OT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575104 ↗
• MalfunctionNov 25, 2020Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove

  ACCORDING TO THE REPORTER, WHEN PUNCTURING THE LEFT JUGULAR VEIN DURING CATHETER INSTALLATION, THE GUIDE WIRE WAS GUIDED BY A NEEDLE BUT IT ENTERED WITH SOME RESISTANCE IN THE ENDOLUMINAL TRACT. GIVEN THE RESISTANCE, THE GUIDE WIRE WAS DECIDED TO REMOVE, BUT IT DID NOT COME OUT, SO THE NEEDLE AND GUIDE WIRE HAD TO BE REMOVED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK, NO TEGO UTILIZED AND NO LUER ADAPTER ISSUE. 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 PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10904670 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123196. One submission often covers many models, so check the product and lot details in each record.

• Z-1885-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1887-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1886-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1889-2025 · Apr 23, 2025 · Open, Classified
  MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1888-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1635-2024 · Mar 15, 2024 · Open, Classified
  Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, aph
• Z-1634-2024 · Mar 15, 2024 · Open, Classified
  Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute a
• Z-1313-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
• Z-1314-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
• Z-1315-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
• Z-2372-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
• Z-2374-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
• Z-2371-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
• Z-2373-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
• Z-2375-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P

…and 33 more.