Palindrome 8888145040PRecalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10884521158030), received between Mar 22, 2018 and Oct 27, 2025 — classified as 1 death, 8 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Break; Break

  ACCORDING TO THE REPORTER, A FLUID LEAKAGE WAS OBSERVED AT THE SUBCUTANEOUS TUNNEL (EXIT SITE) OF A HEMODIALYSIS CATHETER, REQUIRING THE ENTIRE CATHETER TO BE REMOVED. NO BREACH WAS FOUND ON THE REMOVED CATHETER. NOTHING UNUSUAL WAS OBSERVED ABOUT THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LUER ADAPTER ISSUE. FLUSHING WAS DONE, AND NOTHING PARTICULAR WAS OBSERVED. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE. APART FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS OR DAMAGES ON THE PRODUCT AT THE TIME OF THE INCIDENT. THE CATHETER WAS IN PLACE FOR APPROXIMATELY 7 WEEKS. FORTUNATELY, THE ARTERIOVENOUS FISTULA WAS JUST OPERATIONAL, SO IT WAS URGENTLY REPLACED FOR FURTHER CARE (CATHETER REIMPLANTATION) AS A CORRECTIVE ACTION. NO PATIENT HEALTH INCIDENTS. THE ACTION WAS TAKEN IN THE CARE SETTING FOR PATIENT MANAGEMENT. DEVICE CHANGE WITH EXPLANTATION OF THE OFFENDING DEVICE. THE PROCEDURE WAS COMPLETED AFTER THE CORRECTIVE ACTION. THERE WAS NO MEDICAL INTERVENTION OR TREATMENT REQUIRED AS A RESULT OF THE INCIDENT. THERE WAS A SMALL AMOUNT OF BLOOD LOSS, AND THERE WAS NO BLOOD TRANSFUSION REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23396153 ↗
• MalfunctionOct 22, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THERE WAS A FLUID LEAK AT THE LEVEL OF THE SUBCUTANEOUS TUNNEL OF THE HEMODIALYSIS KT (CATHETER), WHICH REQUIRED ITS REMOVAL. NO BREACH WAS FOUND ON THE REMOVED CATHETER. THE DIALYSIS CATHETER HAD TO BE ABLATED, BUT FORTUNATELY, THE PATIENT HAD AN ARTERIOVENOUS FISTULA (AVF) THAT HAD JUST BECOME OPERATIONAL AND WAS URGENTLY USED/PRICKED TO CONTINUE DIALYSIS SESSIONS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359883 ↗
• InjuryJul 11, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, BEFORE TREATMENT, A CRACK WAS OBSERVED IN THE SILICONE ARTERIAL LINE/SIDE AT THE BIFURCATION, SO THE PATIENT WAS UNABLE TO DIALYZE. THE CATHETER HAD BEEN IN USE FOR 13 MONTHS. THE CATHETER WAS NOT REPAIRED. A CLEANING AGENT, CLINELL WIPES, WAS USED ON THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, AND NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. THE PATIENT REMAINED HOSPITALIZED FOR MONITORING AND DIALYSIS. THE PATIENT, WHO WAS ON HOME HEMODIALYSIS (HD), HAD THE CATHETER REMOVED ON (B)(6) 2025, AND A NEW 15.5F (FRENCH) + 23 CM (CENTIMETERS) HEMODIALYSIS CATHETER FROM ANOTHER BRAND WAS INSERTED ON (B)(6) 2025, AS THE INTERVENTION. WITH THE NEW CATHETER, TREATMENT WAS ABLE TO PROCEED AND COMPLETE DIALYSIS. THE HOSPITALIZATION OCCURRED FROM (B)(6) 2025. THERE WAS MINIMAL BLOOD LOSS AS A RESULT OF THE EVENT, AND NO BLOOD TRANSFUSION WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 22481839 ↗
• MalfunctionJun 26, 2025Break; Break

  ACCORDING TO THE REPORTER, THE VENOUS HUB OF THE LINE HAS A CRACK; IT ACTUALLY HAS A PIECE MISSING FROM IT. THE PIECE CAME AWAY FROM THE LINE ONCE THE BUNG WAS ACCESSED. THE CATHETER WAS REPAIRED. CLINELL WIPES WERE THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22341996 ↗
• MalfunctionMay 29, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE DIALYSIS TREATMENT, THE CATHETER HAD A BROKEN VENOUS ADAPTER AND HUB. BESIDES THE REPORTED ISSUE, A TEAR WAS FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THE PATIENT WAS NOT TREATED UNDER GENERAL OR LOCAL ANESTHESIA. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE, AND THE RESULT WAS UNREMARKABLE. OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE INCLUDED CIRCUITS AND EXTENSIONS. THE CUSTOMER WAS USING A COMPETITOR'S EXTENSION LINES WITH THE CATHETER AND A COMPETITOR'S CAPS. EXCESSIVE FORCE WAS NOT USED ON THE DEVICE. THE CLEANING AGENT USED ON THE DEVICE WAS OCTENISEPT, WHICH WAS ALSO TYPICALLY UTILIZED TO CLEAN THE CATHETER IN ITS ENTIRETY. LAVANIDE WAS USED ON DEMAND AT THE SKIN EXIT SITE. THE WOUND DRESSING UTILIZED WAS A LEUKOMED PATCH, WHICH DID NOT INCLUDE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES. THE CLEANING AGENTS WERE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA AND P RIOR TO DRESSING THE AREA. THE PATIENT WAS NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE, CLEANING, OR DRESSING CHANGES. THE CLEANING AGEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22111322 ↗
• MalfunctionApr 22, 2025Break; Break

  ACCORDING TO THE REPORTER, A CRACK WAS NOTICED ON THE LUER ENDS OF THE CATHETER (RED AND BLUE LUER ADAPTERS). THE CATHETER HAS BEEN IN PLACED FOR 6 MONTHS AT THE TIME EVENT. THE CLEANING AGENT USED ON THE DEVICE WAS CLINELLE WIPES. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21883180 ↗
• MalfunctionApr 22, 2025Break; Break

  ACCORDING TO THE REPORTER, A CRACK WAS NOTICED ON THE LUER ENDS OF THE CATHETER (RED AND BLUE LUER ADAPTERS). THE CLEANING AGENT USED ON THE DEVICE WAS CLINELLE WIPES. THE CATHETER HAS BEEN IN PLACED FOR 11 MONTHS AT THE TIME EVENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21882887 ↗
• MalfunctionApr 3, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING NORMAL USE, A CRACK WAS NOTICED ON BOTH LUER ENDS (RED BLUE LUER ADAPTER) OF THE CATHETER. THE CATHETER HAS BEEN IN PLACED FOR 8 MONTHS AT THE TIME EVENT. THE CLEANING AGENT USED ON THE DEVICE WAS CLINELLE WIPES. THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762739 ↗
• MalfunctionDec 3, 2024Break; Break

  ACCORDING TO THE REPORTER, AT THE COMMENCEMENT OF TREATMENT, WHEN THE CLINICIAN WAS REMOVING THE CATHETER LOCK, BLOOD AND AIR ENTERED THE SYRINGE. ON CLOSER INSPECTION, A CRACK WAS NOTED IN THE ARTERIAL LUMEN AND RED (ARTERIAL) LUER. THE LUMEN WAS IMMEDIATELY CLAMPED, AND USE OF THE CATHETER WAS CEASED. THE TREATMENT WAS NOT COMPLETED. ADVICE WAS SOUGHT FROM THE INTERVENTIONAL RADIOLOGY TEAM, WHO AGREED THE DEVICE SHOULD NOT BE USED AND ARRANGED FOR A REPLACEMENT OF THE CATHETER, A WEEK AFTER REPLACEMENT AS A REMEDIAL ACTION. THE TREATMENT WAS COMPLETED 6 DAYS LATER, AFTER THE REINSERTION OF THE CATHETER. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED, INCLUDING THE USE OF PROPHYLACTIC ANTIBIOTICS. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THE BRIEMARK ALCOHOL WIPES WERE THE TYPE OF CLEANING AGENT USED ON THE DEVICE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE FLUSHING WAS DONE PRIOR TO USE, AND THE RESULT WAS NOTHING UNUSUAL. THE TEGO WAS UTILIZED. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833106 ↗
• MalfunctionNov 11, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE CATHETER DYSFUNCTIONED DUE TO CLOT FORMATION. IT WAS ALSO STATED THAT THE PATIENT WITH CATHETERS COMMONLY HAD FIBRIN SHEATH AND CLOTS THAT FORM AROUND THE TIP LEADING TO POOR FLOW RATES AND HIGHER PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652622 ↗
• MalfunctionOct 8, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE CATHETER WAS DYSFUNCTIONING DESPITE TPA BEING INSTILLED. THE DEVICE DEFICIENCY COULD NOT HAVE LED TO A SERIOUS ADVERSE DEVICE EFFECT (SADE). THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20396593 ↗
• MalfunctionOct 7, 2024Break; Break

  ACCORDING TO THE REPORTER, CRACKS IN THE BACK END (LUER ADAPTER) OF THE CATHETER WERE NOTED. 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. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20384683 ↗
• MalfunctionOct 7, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING NORMAL USE, CRACKS IN THE BACK END (LUER ADAPTER) OF THE CATHETER WERE NOTED. THERE WAS NO LEAK. ALCOHOL WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. 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 OUTCOME.

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

  MAUDE report 20383505 ↗
• MalfunctionOct 4, 2024Break; Break

  ACCORDING TO THE REPORTER, CRACKS IN THE BACK END (LUER ADAPTER) OF THE CATHETER WERE NOTED. 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. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20374736 ↗
• MalfunctionOct 3, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE CATHETER HAD A POOR FLOW RATES/DECREASE FLOW RATES AND INTERMITTENT SLOW FLOW RATES AT DIALYSIS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20358421 ↗
• MalfunctionSep 27, 2024Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, AN INSERTION USING A STYLET WAS PERFORMED WITH AN APPROACH FROM THE LEFT INTERNAL JUGULAR VEIN. THE CATHETER WAS SUCCESSFULLY INSERTED, BUT THE GUIDEWIRE COULD NOT BE REMOVED, AND IT FELT THAT IT WAS RISKY. IT WAS STATED THAT BOTH THE GUIDEWIRE AND THE CATHETER WERE REMOVED. IT WAS DECIDED TO FORGO CATHETER INSERTION FOR THE PATIENT THIS TIME AND CONSIDER IT ON A DIFFERENT DAY. THE REPORTED PRODUCT WAS REPLACED WITH A PRODUCT FROM A DIFFERENT MANUFACTURER. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20322459 ↗
• MalfunctionSep 11, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THERE WAS A CRACK ON THE END PIECE OR CONNECTING PIECE OF THE REPORTED PRODUCT. THERE WAS A LEAK ON THE EXIT SITE. A HAIR CRACK AT LUER HUBS WAS THE UNUSUAL THING THAT WAS OBSERVED ON THE PRODUCT. FLUSHING WAS DONE WITH NO ABNORMALITIES. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. BOTH SIDES OF LUER ADAPTER HAD AN ISSUE. NO EXCESSIVE FORCE IS USED ON THE DEVICE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. THE PRODUCT BEING UTILIZED WITH THE DEVICE WAS THE DIALYSIS BLOOD TUBING SET. OCTENISEPT WAS THE CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT WITH OCTENISEPT. THE REMEDIAL ACTION PERFORMED WAS TO REPAIR WITH TWO REPAIR KITS. THE PROCEDURE AND TREATMENT WERE ABLE TO PROCEED AFTER THE RESOLUTION WAS DONE. 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 20193264 ↗
• MalfunctionAug 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THERE WAS A CRACK ON THE END PIECE OR CONNECTING PIECE OF THE REPORTED PRODUCT. THERE WAS A LEAK ON THE EXIT SITE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19907199 ↗
• MalfunctionAug 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THERE WAS A CRACK ON THE END PIECE OR CONNECTING PIECE OF THE REPORTED PRODUCT. THERE WAS A LEAK ON THE EXIT SITE. A HAIRCRACK AT LUER HUBS WAS THE UNUSUAL THING THAT WAS OBSERVED ON THE PRODUCT. FLUSHING WAS DONE WITH NO ABNORMALITIES. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. BOTH SIDES OF LUER ADAPTER HAD AN ISSUE. NO EXCESSIVE FORCE WAS USED ON THE DEVICE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. THE PRODUCT BEING UTILIZED WITH THE DEVICE WAS THE DIALYSIS BLOOD TUBING SET. OCTENISEPT WAS THE CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT WITH OCTENISEPT. THE REMEDIAL ACTION PERFORMED WAS TO REPAIR WITH TWO REPAIR KITS. THE PROCEDURE AND TREATMENT WERE ABLE TO PROCEED AFTER THE RESOLUTION WAS DONE. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 19906995 ↗
• MalfunctionJun 28, 2024Component Missing; Insufficient Device Problem Information; Component Missing; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING IMPLANTATION, THREE CANNULAS (SPLIT AIRLOCK) OF THE KIT WERE BROKEN (SPLIT)/HEAD TORN, AND ONE PRODUCT HAD A SHEATH ISSUE. IT WAS ALSO STATED THAT THE TOP OF THE SPLITTING SHEET DISCONNECT FROM THE SHAFT, SO THE CATHETER COULD NOT BE PLACED INTO THE PATIENT. THE INSERTER DECIDED TO USE THE SPLIT SHEET FROM ANOTHER KIT OF THE SAME LOT AS THE REMEDIAL ACTION. THERE WAS NO DAMAGE TO THE INNER PACKAGE AND OUTER PACKAGING. THE STERILE BARRIER WAS INTACT. THERE WAS NO FLUSHING PRIOR TO USE. THERE WAS NOTHING UNUSUAL ABOUT THE DEVICE BEFORE USE. THE TREATMENT PROCEEDED AND WAS COMPLETED AFTER THE RESOLUTION OF THE SPLIT CANNULA WAS REMOVED AND RESTARTED WITH A NEW SET OF PROCEDURES AS THE CORRECTIVE ACTION TAKEN. THE PATIENT LOST APPROXIMATELY 30 ML OF BLOOD, AND A BLOOD TRANSFUSION WAS NOT REQUIRED. IN ADDITION TO THE REPORTED ISSUE, THERE WERE NO OTHER DEFECTS/DAMAGES TO THE PRODUCT IDENTIFIED AT THE TIME OF THE EVENT. THERE WERE NO OTHER PRODUCTS USED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE. THERE WERE NO CLEANING AGENTS USED ON THE DEVICE. THERE WAS NO PROBLEM WITH THE LUER ADAPTER. THERE WAS NO PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19639152 ↗
• MalfunctionJun 28, 2024Component Missing; Insufficient Device Problem Information; Component Missing; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING IMPLANTATION, THREE CANNULAS (SPLIT AIRLOCK) OF THE KIT WERE BROKEN (SPLIT)/HEAD TORN. IT WAS ALSO STATED THAT THE TOP OF THE SPLITTING SHEET DISCONNECT FROM THE SHAFT, SO THE CATHETER COULD NOT BE PLACED INTO THE PATIENT. THE INSERTER DECIDED TO USE THE SPLIT SHEET FROM ANOTHER KIT OF THE SAME LOT AS THE REMEDIAL ACTION. THERE WAS NO DAMAGE TO THE INNER PACKAGE AND OUTER PACKAGING. THE STERILE BARRIER WAS INTACT. THERE WAS NO FLUSHING PRIOR TO USE. THERE WAS NOTHING UNUSUAL ABOUT THE DEVICE BEFORE USE. THE TREATMENT PROCEEDED AND WAS COMPLETED AFTER THE RESOLUTION OF THE SPLIT CANNULA WAS REMOVED AND RESTARTED WITH A NEW SET OF PROCEDURES AS THE CORRECTIVE ACTION TAKEN. THE PATIENT LOST APPROXIMATELY 30 ML OF BLOOD, AND A BLOOD TRANSFUSION WAS NOT REQUIRED. IN ADDITION TO THE REPORTED ISSUE, THERE WERE NO OTHER DEFECTS/DAMAGES TO THE PRODUCT IDENTIFIED AT THE TIME OF THE EVENT. THERE WERE NO OTHER PRODUCTS USED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE. THERE WERE NO CLEANING AGENTS USED ON THE DEVICE. THERE WAS NO PROBLEM WITH THE LUER ADAPTER. THERE WAS NO PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19638872 ↗
• MalfunctionJun 28, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING IMPLANTATION, THE CANNULAS (SPLIT AIRLOCK) OF THE KIT WERE BROKEN (SPLIT)/HEAD TORN. IT WAS ALSO STATED THAT THE TOP OF THE SPLITTING SHEET DISCONNECT FROM THE SHAFT, SO THE CATHETER COULD NOT BE PLACED INTO THE PATIENT. THE INSERTER DECIDED TO USE THE SPLIT SHEET FROM ANOTHER KIT OF THE SAME LOT AS THE REMEDIAL ACTION. THERE WAS NO DAMAGE TO THE INNER PACKAGE AND OUTER PACKAGING. THE STERILE BARRIER WAS INTACT. THERE WAS NO FLUSHING PRIOR TO USE. THERE WAS NOTHING UNUSUAL ABOUT THE DEVICE BEFORE USE. THE TREATMENT PROCEEDED AND WAS COMPLETED AFTER THE RESOLUTION OF THE SPLIT CANNULA WAS REMOVED AND RESTARTED WITH A NEW SET OF PROCEDURES AS THE CORRECTIVE ACTION TAKEN. THE PATIENT LOST APPROXIMATELY 30 ML OF BLOOD, AND A BLOOD TRANSFUSION WAS NOT REQUIRED. IN ADDITION TO THE REPORTED ISSUE, THERE WERE NO OTHER DEFECTS/DAMAGES TO THE PRODUCT IDENTIFIED AT THE TIME OF THE EVENT. THERE WERE NO OTHER PRODUCTS USED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE. THERE WERE NO CLEANING AGENTS USED ON THE DEVICE. THERE WAS NO PROBLEM WITH THE LUER ADAPTER. THERE WAS NO PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19638235 ↗
• InjuryJul 7, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE PATIENT'S RIGHT CHEST CATHETER LINE WAS ATTEMPTED TO BE ACCESSED IN AN OUTPATIENT HOSPITAL APPOINTMENT (PATIENT ROOM). THE PATIENT REPORTED TO THE AMBULATORY UNIT FOR AN APPOINTMENT FOR A BLOOD DRAW, THE RN (REGISTERED NURSE) FLUSHED EASILY THE RED LUMEN WITH A 10ML NORMAL SALINE SYRINGE, HOWEVER, WHEN THE RN USED AN EMPTY 5 ML SYRINGE TO PULL THE BLOOD SAMPLE OFF THE CENTRAL LINE, ONLY 1 ML SALINE AND A FLASH OF BLOOD RETURNED INTO THE SYRINGE. THE RED LUMEN OF THE LINE WAS NOT DRAWING BACK BLOOD. THE ADDITIONAL RESISTANCE/PULLING ON THE SYRINGE HAD A MIXTURE OF AIR AND BLOOD APPROXIMATELY 1 ML CAME BACK INTO THE SYRINGE. THE RN STOPPED ATTEMPTING TO DRAW FROM THE RED LUMEN AND MOVED ON TO THE BLUE LUMEN TO DRAW BLOOD TO OBTAIN LABS; THE BLUE LUMEN WAS ABLE TO BE FLUSHED AND WAS ABLE TO SUCCESSFULLY DRAW BLOOD. THE PATIENT BECAME MORE CONFUSED, LESS RESPONSIVE AND AT THE END OF THE BLOOD DRAW, THE PATIENT STARTED COMPLAINING OF ACUTE ONSET OF SHORTNESS OF BREATH SO A MEDICAL EMERGENCY RESPONSE WAS ACTIVATED. A REGISTERED RESPIRATORY THERAPIST (RRT) WAS THEN CALLED FOR A POSSIBLE STROKE. WHILE WAITING FOR THE RAPID RESPONSE TEAM (RRT) TO RESPOND TO TH

  Patient problems: Air Embolism; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Confusion/ Disorientation; Dyspnea; Paralysis; Unintended Radiation Exposure

  MAUDE report 17279873 ↗
• InjuryMay 30, 2023Disconnection; Disconnection

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, MINUTES WITHIN THE PATIENT¿S CONNECTION, A DISCONNECTION ACCIDENT BETWEEN A HEMODIALYSIS LEG CATHETER AND ANOTHER MANUFACTURER¿S DIALYSIS BLOODLINE OCCURRED IN THE CHRONIC HEMODIALYSIS SECTOR. THE CONNECTION ITSELF WAS CARRIED OUT IN ACCORDANCE WITH THE BEST PRACTICES, IN FULL COMPLIANCE WITH THE RECOMMENDATIONS OF THE DEPARTMENT. THE DISCONNECTION INVOLVED THE DIALYSIS VENOUS LINE WHICH WAS THE BLOOD OUTLET LINE OF THE EXTRACORPOREAL CIRCUIT, WHICH RETURNED THE BLOOD TO THE PATIENT. AS USUAL, THE VENOUS LINE DISCONNECTION WAS NOT ACCOMPANIED BY A DROP IN VENOUS PRESSURE AND THERE WAS NO ALARM ON THEDIALYSIS MACHINE. THE EXTRACORPOREAL CIRCULATION (CARDIOPULMONARY BYPASS) PUMP CONTINUED TO RUN/ROTATE. THERE WAS AN ESTIMATED BLOOD LOSS OF ABOUT 1.5 LITERS. AT THIS MOMENT, THE ALARM ON THE ARTERIAL LINE OF THE CIRCUIT RANG, AND IT WAS CORRESPONDED BY A DROP IN THE PATIENT¿S BLOOD PRESSURE. THIS HEMODIALYSIS SYSTEM ALARM FAULT WAS INHERENT IN THE TECHNIQUE AND WAS WELL KNOWN TO DIALYSIS TEAMS. THE NURSE WENT TO THE PATIENT¿S BED, NOTICED THE DISCONNECTION AND BLOOD LOSS. THE PATIENT THEN LOST CONSCIOUSNESS. THE EMERGENCY PROCEDURES W

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Loss of consciousness; Low Blood Pressure/ Hypotension

  MAUDE report 17022815 ↗
• MalfunctionFeb 17, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, A PERMANENT CATHETER WAS PLACED WITH A VALVE PULL-APART SHEATH FUNCTION (SPLIT SHEATH). WHEN THE GRIPS BROKE OR CRUMBLED (SPLIT SHEATH DYSFUNCTION), THE PHYSICIAN WANTED TO COMPLETE THE PROCEDURE AND WITHDRAW THE VALVE PULL SHEATH AFTER CATHETERIZATION. THE REMAINING SURROUNDING SHEATH WAS CONTINUED/STILL ON THE CATHETER IN THE PATIENT'S VEIN. THE DOCTOR SOLVED THE PROBLEM BY GETTING HELP FROM A COLLEAGUE, FIXING TWO PEGS ON EACH END OF THE REMAINING SPLIT SHEET, PULLED THE HARD SHEET APART, AND RELEASING THE REST OF THE CATHETER WITHOUT ANY RESIDUE IN THE PATIENT. CONSIDERED A CLOSE CALL BECAUSE THE REST OF THE SPLIT SHEET COULD HAVE CAUSED IATROGENIC DISCOMFORT TO THE PATIENT. THE CATHETER WAS REPAIRED. THERE WERE NO CONSEQUENCES TO THE INCIDENT BECAUSE IT WAS AVOIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16398636 ↗

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-1888-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision H 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-1886-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision HSI 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-1885-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision 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-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-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-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.