Palindrome 8888145039PRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10884521158023), received between Mar 30, 2018 and May 26, 2026 — classified as 4 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026

  INJURY OCCURRED, PULMONARY AIR EMBOLUS. DURING PLACEMENT OF TUNNELED CENTRAL VENOUS CATHETER, THE PEEL AWAY SHEATH VALVE FAILED AND A LARGE BOLUS OF AIR WAS SUCKED INTO THE SHEATH AND INTO THE HEART PROMPTING IMMEDIATE ADVANCED AIRWAY PROCEDURES, PATIENT REPOSITIONING, AND EMERGENT ANESTHESIA RESPONSE.

  Patient problems: Hemodynamic instability; Obstruction/Occlusion; Pulmonary Embolism; Reduced Blood Flow

  MAUDE report 25277324 ↗
• MalfunctionDec 11, 2025Break; Break

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, LOCKED WAS REMOVED AND ARTERIAL LUMEN FLUSHED SUCCESSFULLY. THE VENOUS LUMEN WITH 10 MILLILITERS FLUSH OF SALINE LEAKED BACK DOWN VIA THE EXIT SITE. THE PATIENT WAS SITTING UPRIGHT AT THE TIME. THE SECOND 10 ML FLUSH ATTEMPTED TO DIAGNOSE, AND THE SAME THING HAPPENED. UNABLE TO FIND SOURCE OF LEAK AS ABOVE EXIT SITE IN THE TUNNEL. CATHETER DEEMED UNUSABLE AND NOT ACCESSED AGAIN. THEY ATTENDED THE FOLLOWING BLOOD TESTS: FULL BLOOD COUNT, RENAL BIOCHEMISTRY AND C-REACTIVE PROTEIN. PATIENT WAS DEEMED STABLE AND WAS DISCHARGED HOME. TREATMENT WAS NOT CONTINUED, AND THE DECISION WAS MADE TO NOT IMPLANT ANOTHER CATHETER, BUT TO ATTEMPT TO USE ANOTHER CATHETER INSERTED ON THE SAME DAY AS THE ORIGINAL CATHETER IMPLANT FOR DIALYSIS. THEY CHANGED THE CENTRAL VENOUS ACCESS DEVICE (CVAD) DRESSINGS THREE TIMES A WEEK UNTIL REMOVAL AS PATIENT HAD BLOOD OOZING FROM EXIT SITE SPORADICALLY, AND THE DRESSINGS WERE LIFTING DUE TO THE HEAT. THE PATIENT HAD CHANGED THE DRESSING AT HOME WITHIN THE FIRST WEEK AND WAS ADVISED TO PRESENT TO THE UNIT RATHER THAN DO IT ALONE. THEY USE CHLORHEXIDINE AND ALCOHOL TO CLEAN THE ACCESS SITE AND KALTOSTAT/AMD FOAM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782991 ↗
• InjuryAug 21, 2025Material Fragmentation; Difficult to Remove; Material Fragmentation; Difficult to Remove

  ACCORDING TO THE REPORTER, WHEN PLACING THE REPORTED PRODUCT, THE GUIDEWIRE BECAME STUCK HALFWAY THROUGH, BUT WHEN THEY TRIED TO REMOVE IT ANYWAY, THE TIP OF THE GUIDEWIRE BROKE OFF HALFWAY THROUGH AND REMAINED SUBCUTANEOUSLY IN THE INTERNAL JUGULAR VEIN. 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 PRIOR TO USE, AND THERE WAS NO PROBLEM. THERE WAS NO LEAK. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO CONNECTOR ISSUE. THE INSERTION SITE WAS NOT HANDLED PRIOR TO PRODUCT PLACEMENT. THE GUIDEWIRE PROVIDED WITH THE KIT WAS BEING USED. 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, THEY HAD TO SURGICALLY INCISE IT AND REMOVE THE BROKEN GUIDEWIRE. AS A RESULT, THE TIP OF THE GUIDEWIRE BROKE OFF AND WAS DAMAGED AND DEFORMED. ALL OF THE GUIDEWIRE, INCLUDING THE TIP THAT BROKE OFF, WAS SUCCESSFULLY REMOVED DURING THE PROCEDURE. AN X-RAY WAS DONE DURING THE POST-PROCEDURE. HOWEVER, THE GUIDEWIRE WAS NOT REPLACED, AND THE PR

  Patient problems: Foreign Body In Patient

  MAUDE report 22864341 ↗
• 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 22378803 ↗
• MalfunctionJul 1, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22378620 ↗
• MalfunctionJun 23, 2025Material Puncture/Hole; Detachment of Device or Device Component; Material Puncture/Hole; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PATIENT DEVICE MAINTENANCE, THE CATHETER BROKE WHILE BATHING. WHEN CHECKED AT THE OPENING OF THE CRACK, THERE ARE TRACES OF THE RESECTION. THE EXTENSION TUBE WAS DETACHED FROM THE LUER ADAPTER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO LEAK AND NO ISSUE WITH THE LUER ADAPTER. THERE WERE NO OTHER PRODUCTS 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 CATHETER WAS REPLACED. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSIONS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311878 ↗
• MalfunctionMay 28, 2025Break; Break

  ACCORDING TO THE REPORTER, ABOUT HALF A YEAR HAD PASSED SINCE THE PATIENT¿S CATHETER WAS PLACED. ALTHOUGH NO PROCEDURE (OPERATION) WAS PERFORMED THAT APPLIED NON-HUMAN FORCE (LOADS), SUCH AS THE USE OF FORCEPS, HUB BREAKAGE (CRACKS CAN BE VISUALLY CONFIRMED) OCCURRED DURING DIALYSIS TREATMENT. THERE WAS NO LEAK. TEGO WAS NOT USED. CLOSED PLUGS WERE USED TO LOOSEN AND TIGHTEN THE CONNECTION. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS ARE BEING UTILIZED WITH THE DEVICE. NO OTHER VISIBLE DEFECTS/DAMAGES WERE FOUND ON THE PRODUCT. ALCOHOL WAS THE CLEANING AGENT THAT WAS TYPICALLY UTILIZED TO CLEAN THE CATHETER IN ITS ENTIRETY. SEPSIDERM WAS NOT USED TO CLEAN THE CATHETERS. THERE WAS NO PROTOCOL CHANGE FOR CLEANING AGENTS. THE PATIENT WAS NOT USING ANY TYPE OF CLEANING AGENTS OR ANTIBIOTICS ON THE CATHETER. THE INTERVENTION/TREATMENT AND REMEDIAL ACTION REQUIRED AS A RESULT OF THE EVENT WERE CATHETER REMOVAL AND INSERTION. 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 22096611 ↗
• MalfunctionMar 21, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING THE OPERATION, WHEN THE GUIDEWIRE FROM THE KIT WAS INTRODUCED INTO A TEMPORARY CATHETER, THE GUIDEWIRE UNRAVELED UPON REMOVAL. IT WAS ALSO STATED THAT IT UNCOILED INSIDE THE BODY. THERE WAS NOT ANY RESISTANCE OBSERVED WHEN INSERTING THE GUIDEWIRE, AND THERE WAS NO TOOL USED WHEN TRYING TO REMOVE IT. THE GUIDEWIRE WAS REMOVED SLOWLY, WITH NO EXCESSIVE FORCE, TO AVOID BREAKAGE. THERE WERE NO ISSUES WITH THE LUER ADAPTER, AND NO OTHER DEFECTS OR DAMAGES WERE OBSERVED ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE, AND THE CATHETER ITSELF WAS FINE. NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE. THE REPORTED PRODUCT WAS NOT REPLACED. PATIENT WAS FINE, AND THERE WERE NO CONSEQUENCES DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 21662652 ↗
• MalfunctionNov 26, 2024Break; Break

  ACCORDING TO THE REPORTER, ON COMMENCEMENT OF PHOTOPHERESIS TREATMENT, WHEN THE CLINICIAN WITHDREW THE CATHETER LOCK, AIR AND BLOOD ENTERED THE SYRINGE. UPON CLOSER INSPECTION, A CRACK WAS OBSERVED IN THE BLUE (VENOUS LUMEN) LUER. THE AFFECTED CATHETER HAD BEEN INSERTED INTO THE PATIENT FOR ABOUT 430 DAYS BEFORE THE ISSUE OCCURRED. THERE WERE NO OTHER DAMAGES FOUND ON THE PRODUCT WHERE THE CRACK WAS OBSERVED. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER DEFECTS FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO LEAK. THE CATHETER WAS NOT REPAIRED. TEGO WAS UTILIZED, AND THE CLEANING AGENTS USED ON THE PRODUCT WERE BRIEMARK ALCOHOL WIPES, AND THE SKIN SURROUNDING THE CATHETER WAS CLEANED WITH N/SALINE OR CHLOROPREP. THE CLEANING AGENTS WERE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENTS TO THE AREA. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THE PRODUCTS BEING UTILIZED WERE COMPETITORS BRANDS OF APHERESIS KITS, ECP (EXTRACORPOREAL PHOTOPHERESIS KITS), AND LUER LOCK SYRINGES. THE EXTENSION WAS IMMEDIATELY CLAMPED AND CAPPED WITH A BD BUNG (CAP) AND WAS NOT USED. THE INCIDENT WAS REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786094 ↗
• MalfunctionOct 2, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE CATHETER HAD AN OCCLUSION AND CLOTTED WITH NO RESOLUTION DESPITE TPA. THE PERMCATH WAS EXCHANGED THE FOLLOWING DAY. IT WAS STATED THAT THE DEVICE DEFICIENCY COULD NOT HAVE LED 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20350463 ↗
• MalfunctionSep 30, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE CENTRAL VENOUS CATHETER (CVC) HAD MALFUNCTIONED EITHER IN ASPIRATION OR IN INFUSION. THE CATHETER HAD BEEN IN PLACE FOR 2 MONTHS. THE LOCAL THERAPY WAS WITH UROKINASE (B)(4) INTERNATIONAL UNITS PER LUMEN (BOTH ARTERIAL AND VENOUS) FOR 45 MINUTES, WHICH WAS THE REMEDIAL ACTION PERFORMED. AFTER THERAPY, CVC FUNCTION WAS RESTORED. MEDICAL 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 20340804 ↗
• MalfunctionAug 13, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DIALYSIS WAS IN PROGRESS, THE TAPE ON THE CATHETER WAS REMOVED, AND BLOOD SPURTED OUT ONTO THE PILLOW. THE LEAK WAS AT THE EXTENSION TUBE AT THE RED LUER ADAPTER. THE DIALYSIS WAS ABORTED. THE RENAL REG WAS ADVISED. THE PATIENT WAS TO PRESENT THE NEXT DAY FOR CATHETER REMOVAL, NEW CATHETER INSERTION, AND DIALYSIS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19977388 ↗
• MalfunctionAug 13, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, PRE-DIALYSIS, THE LUMEN WAS FLUSHED WITH NORMAL SALINE, AND SPURTED OUT FROM A HOLE THAT WAS FOUND IN THE CATHETER. THE LEAK WAS AT THE EXTENSION TUBE AT THE BLUE LUER ADAPTER. THE PRODUCT WAS REPLACED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19974279 ↗
• MalfunctionJan 26, 2024Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, WHEN THE MEDICAL DOCTOR (MD) WAS PLACING THE 19CM CATHETER, THE CATHETER WAS INSERTED THROUGH THE PEEL-AWAY SHEATH WITHIN THE KIT. WHEN THE MEDICAL DOCTOR BEGAN TO USE THE PEEL-AWAY MECHANISM, THE UPPER PORTION (T-SHAPED PORTION) OF THE PEEL-AWAY SHEATH BROKE OFF, WHICH MEANT THAT THERE WAS A COMPLETE SEPARATION OF THE SHEATH INTO TWO OR MORE PIECES. THIS ONLY HAPPENED TO ONE SIDE OF THE T-SHAPED PORTION. THE PIECES OF THE SHEATH DID NOT FELL INTO THE PATIENT'S BODY. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS OR DAMAGES FOUND ON THE PRODUCT. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WAS NO RESISTANCE WHEN THE CATHETER WAS PLACED OR INSERTED INTO THE PEEL-AWAY SHEATH. AS A REMEDIALACTION, THE MEDICAL DOCTOR USED HIS HAND AND A HEMOSTAT TO PULL APART THE PEEL-AWAY SHEATH. THE PEEL-AWAY SHEATH WAS NOT REPLACED AND WAS CONTINUED TO BE USED, AND THE CATHETER WITHIN THE REPORTED KIT WAS USED AND PLACED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587264 ↗
• MalfunctionOct 19, 2023Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, AFTER CATHETER INSERTION ON (B)(6) 2023, A BEND OCCURRED IN THE CATHETER SHAFT THAT MADE IT IMPOSSIBLE TO PERFORM DIALYSIS TREATMENT ON THE DAY OF THE EVENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO LEAK AND NO PROBLEM WITH THE CONNECTOR. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO VISIBLE DEFECTS OR DAMAGES NOTED WITH THE CATHETER. FLUSHING WAS DONE PRIOR TO USE WITHOUT ANY PROBLEM. TEGO WAS NOT USED, AND NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. HYPOCHLOROUS ACID WAS THE CLEANING AGENT USED IN THIS DEVICE. THE INSERTION SITE WAS NOT HANDLED PRIOR TO PRODUCT PLACEMENT. THE CATHETER HAD BEEN IN PLACE FOR ABOUT A WEEK. IT WAS MENTIONED THAT THE PRODUCT NEEDED TO BE REPLACED WITH THE SAME PRODUCT, AND IT WAS REPLACED ON (B)(6) 2023. AS A REMEDIAL ACTION, THE PLACEMENT POSITION OF THE CATHETER WAS ADJUSTED. THE TREATMENT WAS COMPLETED. THERE WAS NO BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INTERVENTION OR TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966983 ↗
• MalfunctionAug 4, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE VENOUS LUMEN HAD DARK RED BLOOD IN THE LUMEN UP TO THE CLAMP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17465793 ↗
• MalfunctionAug 4, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, UPON ARRIVAL TO HD (HEMODIALYSIS), THE WRITER NOTED THAT THE VENOUS LUMEN HAD DARK RED BLOOD IN THE LUMEN UP TO THE CLAMP. THE PATIENT INFORMED THE WRITER THAT THIS HAS BEEN HAPPENING FREQUENTLY RECENTLY. AS PER NOTE ENTERED BY THE ACCESS NURSE, TEGOS AND CLAMPS WERE CHANGED ON BOTH LUMENS PRIOR TO HD (HEMODIALYSIS) INITIATION. DURING CENTRAL VENOUS CATHETER (CVC) CARE THE WRITER NOTED THAT ONCE THE TEGOS WERE CHANGED, THAT FOLLOWING ASPIRATION OF BOTH LUMENS. ONCE LUMENS WERE FLUSHED WRITER NOTED THAT BLOOD WAS BACKING UP INTO THE OPPOSITE LUMEN (VENOUS LUMEN FLUSHED AND BLOOD BACKED UP INTO ARTERIAL LUMEN UP TO CLAMP AND WHEN ARTERIAL LUMEN WAS FLUSHED BLOOD BACKED UP INTO VENOUS LUMEN). THEN LUMENS WERE FLUSHED AGAIN AND NO BACKING UP INTO LUMENS WAS NOTED. THEREFORE, HD WAS INITIATED. DURING RINSE BACK AT END OF TREATMENT (2130), THE WRITER NOTED THAT WHILE RINSING BLOOD BACK FOLLOWING THE ARTERIAL LUMEN HAVING BEEN ALREADY FLUSHED WITH 10 CC (CUBIC CENTIMETER) NS (NORMAL SALINE), BLOOD BEGAN BACKING UP INTO ARTERIAL LUMEN UP TO CLAMP. ONCE RINSE BACK WAS COMPLETED, WRITER ONCE AGAIN FLUSHED ARTERIAL LUMEN WITH ANOTHER 10 CC NS. VENOUS LUMEN WAS FLUSH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17465553 ↗
• MalfunctionFeb 28, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING INSERTION AT THE RIGHT INTERNAL JUGULAR, THE PART NEAR THE TIP OF THE SHEATH WAS TORN OFF. THERE WAS NO LEAK. ALCOHOL WAS THE CLEANING AGENT WAS USED IN THIS DEVICE. THERE WAS NO PROBLEM WITH THE LUER ADAPTER. THE INSERTION SITE WAS HANDLED WITH ALCOHOL PRIOR TO PRODUCT PLACEMENT. NO RESISTANCE WHEN INSERTING THE PULL APART SHEATH. NO EXCESSIVE FORCE APPLIED ON THE DEVICE. NOTHING UNUSUAL OBSERVED PRIOR TO USE. NO FLUSHING PRIOR TO USE. THE REPORTED PULL APART SHEATH USED WAS THE ONE INCLUDED IN THE KIT. THE DIMENSION OF REPORTED SHEATH DID MATCH WHAT WAS INDICATED ON THE LABEL. THERE WAS NO DIMENSION ISSUE NOTED ON THE SHEATH. REPLACEMENT WAS THE REMEDIAL ACTION PERFORMED TO ADDRESS THE ISSUE AND THE PROCEDURE WAS COMPLETED. BLOOD TRANSFUSION WAS NOT REQUIRED. THE PATIENT HAD NO VESSEL DAMAGE DUE TO THE EVENT. NO OTHER INTERVENTION/TREATMENT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452330 ↗
• MalfunctionSep 16, 2020Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THERE WAS A BLOOD LEAK AT THE ARTERIAL LUMEN(JUNCTION OF EXTENSION TUBE AND BIFURCATE) DURING CONNECTION TO A DIALYSIS MACHINE. IT WAS MENTIONED UPON VISUAL INSPECTION BY USING NORMAL SALINE THAT IT WAS UNABLE TO SEE THE CRACK BUT THERE WAS NO NORMAL SALINE LEAKAGE NOTED. IT WAS ALSO MENTIONED WHEN ASPIRATING THE LUMEN, MICRO BUBBLES WERE SEEN IN THE EXTENSIONS. THERE WAS NO ISSUE FOUND ON BIFURCATE. THERE WAS BLOOD LOSS OF LESS THAN 1 MILLILITER (ML) AND BLOOD TRANSFUSION WAS NOT REQUIRED. FLUSHING WAS DONE PRIOR TO TREATMENT AS USUAL PART OF ROUTINE. IT WAS ALSO MENTIONED THAT FLUSHING WAS DONE PRIOR TO CATHETERIZATION AND THE RESULT WAS NORMAL. THE CATHETER WAS REPAIRED, THERE WAS NO TEGO UTILIZED, NO LUER ADAPTER ISSUE AND THE INSERTION SITE AND THE CATHETER WAS CLEANED WITH CHLORHEXIDINE 2% IN 70% ISOPROPYL ALCOHOL. ALCOHOLIC CHLORHEXIDINE WAS USED AS CLEANING AGENT TO CLEAN THE ADAPTERS AND TEGADERM IV ADVANCED AS DRESSING. THE TREATMENT WAS STOPPED. THEY HAD TO USE A REPAIR KIT TO RESOLVE THE ISSUE AND ON THE NEXT DAY, THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10543121 ↗
• InjurySep 15, 2020Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING INSERTION OF A PALINDROME CATHETER, THE GUIDE WIRE REMAINED INSIDE THE PATIENTS ATRIUM AND IT WAS NOT ABLE TO BE REMOVED WITH THE USUAL PROCEDURES. PATIENT WAS THEN TRANSFERRED TO ANOTHER HOSPITAL FOR INTERVENTION AND EVALUATION BY A HEART SURGEON. THE GUIDE (WIRE) WAS WITHDRAWN WITHOUT INCIDENT. THE PATIENT WAS SENT TO THE ICU (INTENSIVE CARE UNIT) AND SUBSEQUENTLY RETURNED TO BASE HOSPITAL. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, AND THERE WAS NO LUER ADAPTER ISSUE. THE EVENT LED TO PATIENT EXTENDED HOSPITALIZATION. THE PATIENT WAS STABLE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 10537738 ↗
• MalfunctionJul 2, 2020Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, THE INSERTION SITE WAS CLEANED WITH STICK AND LEAK WAS OBSERVED ON COMMENCEMENT OF TREATMENT BY VISUALIZING A SMALL AMOUNT OF BLOOD (2ML) AT THE CRACK WHERE THE LUER JOINS THE SILICONE EXTENSION. THE TREATMENT WAS STOPPED, AND THE PATIENT WAS ADMITTED TO THE WARD FOR CATHETER REMOVAL AND REPLACEMENT THE FOLLOWING DAY, THE REPLACEMENT CATHETER WAS PLACED ON THE OPPOSITE SIDE (LEFT SIDE) AND THERE WERE NO ADVERSE EVENTS FOLLOWING THE REPLACEMENT. FLUSHING WAS DONE PRIOR TO USE, CATHETER WAS NOT REPAIRED, THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, CLAMP WAS MOVED PERIODICALLY. TEGO WAS UTILIZED, THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT, THERE WERE NO ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. BLOOD TRANSFUSION WAS NOT REQUIRED, THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10227370 ↗
• MalfunctionApr 24, 2020Break; Break

  ACCORDING TO THE REPORTER, THE CATHETER'S HUB WAS FOUND TO HAVE A VERTICAL CRACK. IT WAS ALSO STATED THAT THE USAGE PERIOD WAS 1 YEAR AND 2 MONTHS. THEY HAD TO USE A THREE-WAY (T SHAPE) STOPCOCK BETWEEN THE CONNECTION PART AND THE CIRCUIT SO LESS LOAD WOULD BE APPLIED THAN DIRECTLY CONNECTING IT. IT WAS MENTIONED THAT THEY REPLACED THE THREE-WAY (T SHAPE) STOPCOCK ONCE A WEEK AND MUSKIN WAS USED FOR DISINFECTION. THE DEGREE OF CRACKING WAS EXTREMELY SMALL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9998147 ↗
• MalfunctionApr 24, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING CONNECTION WITH THE CIRCUIT, THE CATHETER'S HUB WAS FOUND TO HAVE A VERTICAL CRACK. IT WAS MENTIONED THAT THE USAGE PERIOD WAS 1 YEAR AND 2 MONTHS. THEY HAD TO USE A THREE-WAY STOPCOCK (T SHAPE) BETWEEN THE CONNECTION PART AND THE CIRCUIT SO LESS LOAD WOULD BE APPLIED THAN THAT OF DIRECTLY CONNECTING IT. THE THREE-WAY STOPCOCKS WERE REPLACED ONCE A WEEK. MUSKIN WAS USED FOR DISINFECTION. THERE WAS NO LEAK. A REPLACEMENT CATHETER WAS INSERTED AS A RESULT OF THE EVENT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9997939 ↗
• MalfunctionFeb 17, 2020Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING DIALYSIS, WHEN THE ARTERIAL LUMEN LOCKING SOLUTION WAS ASPIRATED, BLOOD LEAK WAS NOTED AROUND THE LUER LOCK OF THE CATHETER'S EXTENSION. IT WAS ALSO STATED THAT THE TREATMENT WAS DELAYED UNTIL THE LUER (ARTERIAL) WAS REPAIRED WITH A REPAIR KIT. THE TREATMENT OCCURRED 3 HOURS AFTER THE USUAL SCHEDULE TIME. ALCOHOLIC CHLORHEXIDINE WAS USED AS CLEANING AGENT IN THE DEVICE. TEGO WAS UTILIZED AND A CRACK WAS OBSERVED IN THE LUER ADAPTER. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT AND THERE WAS NO PATIENT SYMPTOMS OR COMPLICATION ASSOCIATED WITH THIS EVENT. THERE WAS A BLOOD LOSS OF APPROXIMATELY 2 MILLILITERS AND THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9717830 ↗
• MalfunctionDec 6, 2019Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, UPON COMMENCEMENT OF HEMODIALYSIS TREATMENT, THERE WAS BLOOD FOUND TO BE SQUIRTED OUT OF THE VENOUS LUMEN OF THE DEVICE WHEREIN THERE WAS NOTED TO LEAKAGE FROM THE LUER ADAPTER. A CRACK WAS OBSERVED IN THE VENOUS LUER ADAPTER. THERE WAS AN EVENTUAL BLOOD LOSS OF LESS THAN 10 ML BUT BLOOD TRANSFUSION WAS NOT NEEDED. THE EXTRACORPOREAL CIRCUIT WAS IMMEDIATELY RETURNED TO THE PATIENT AND TREATMENT WAS CEASED. IT WAS ALSO NOTED THAT TEGO WAS UTILIZED AND THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. ALCOHOLIC CHLORHEXIDINE WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, A REPAIR KIT HAD BEEN SENT WHEREIN THE CATHETER WAS NOTED TO BE REPAIRED AND TREATMENT WAS DONE THE NEXT DAY. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE AS THIS DONE BY HAND. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9431766 ↗

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-1889-2025 · Apr 23, 2025 · Open, Classified
  MAHURKAR 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-1888-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision H 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-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-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-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-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-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-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
• 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-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-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-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

…and 33 more.