Palindrome 8888145015Recalls & reported problems

Summary

The FDA's MAUDE database contains 219 adverse event reports that list this exact device (DI 20884521013169), received between Mar 29, 2017 and Dec 3, 2025 — classified as 1 death, 18 injuries, 200 malfunctions.

The most frequently reported specific device problem is “Break” (85 reports).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 22, 2023Open, Classified

   Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the catheter body.

   Z-2632-2023 · Root cause: Under Investigation by firm · FDA record ↗

2. Jun 8, 2022Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 219 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, DURING THE INTERVENTIONAL RADIOLOGY PROCEDURE IN THE HEMODYNAMICS AREA OF THE HOSPITAL, FOLLOWING ASEPSIS AND ANTISEPSIS UNDER SEDATION, THE CATHETER WAS PLACED IN THE LEFT JUGULAR VEIN. FOLLOWING PUNCTURE, TUNNELING, AND ADVANCEMENT OF THE CATHETER TO THE RIGHT ATRIUM UNDER FLUOROSCOPIC AND ULTRASOUND GUIDANCE, AND PROGRESSIVE DILATION TO 15 FRENCH, LEAVING A PEEL AWAY 15 FRENCH INTRODUCER. THE CATHETER WAS THEN TUNNELED FROM THE LEFT SUPRACLAVICULAR PORTION INTO THE LEFT JUGULAR REGION, WHERE THE 14.5 X 23 CATHETER INTRODUCER WAS PLACED AND LEFT IN THE VEIN. THE CATHETER WAS TESTED FOR ARTERIAL LUMEN DYSFUNCTION, AND THE PATENCY AND BLOOD RETURN TESTS WERE UNSUCCESSFUL. KINKING WAS RULED OUT BY FLUOROSCOPY. EVEN THOUGH TRACTION MANEUVERS WERE PERFORMED TO MODIFY THE CATHETER ANGULATION, VENOUS RETURN DID NOT IMPROVE. IT WAS OBSERVED THAT THE CATHETER WAS DYSFUNCTIONAL. THE LINE WAS NOT HARD TO FLUSH WITH THE SYRINGE, AND THERE WAS NO BLOOD RETURN PRIOR TO SYRINGE FLUSH. HEPARIN WAS USED AS AN ANTICOAGULANT DURING THE PROCEDURE, AND REVERSE FLOW WAS UNSUCCESSFUL. THE CATHETER WAS FLUSHED BEFORE INSTALLATION WITHOUT ANY ISSUES. NO OTHER PRODUCTS WERE UTIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23711463 ↗
• MalfunctionNov 6, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT, DIAGNOSED WITH CHRONIC RENAL FAILURE IN THE UREMIC STAGE, UNDERWENT ROUTINE HEMODIALYSIS TREATMENT (THREE TIMES WEEKLY) AT THE HOSPITAL. ON (B)(6) 2025, A CHRONIC CATHETER WAS IMPLANTED VIA THE RIGHT INTERNAL JUGULAR VEIN FOR LONG-TERM HEMODIALYSIS ACCESS. ON (B)(6) 2025, THE PATIENT WAS ADMITTED TO THE DEPARTMENT FOR OUTPATIENT HEMODIALYSIS; THE TREATMENT WAS COMPLETED SMOOTHLY. AFTER THE HEPARIN CAP WAS REMOVED, A LONGITUDINAL CRACK WAS OBSERVED AT THE THREADED CONNECTION OF THE CENTRAL VENOUS CATHETER'S VENOUS END, BUT NO ALARM WAS TRIGGERED BY THE DIALYSIS MACHINE. AFTER DISCONNECTION, FURTHER INSPECTION REVEALED NO BLEEDING AT THE CRACK SITE. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE PATIENT WAS ADVISED TO UNDERGO ENHANCED MONITORING AND NURSING CARE. AS A REMEDIAL ACTION AND INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT, THE CATHETER WAS REPAIRED BY REPLACING THE CONNECTOR OF THE CHRONIC CATHETER WITH A N EW ONE, ENSURING THE CONTINUED SMOOTH PROGRESS OF DIALYSIS TREATMENT. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE EVENT. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23488001 ↗
• MalfunctionNov 6, 2025Break; Break

  ACCORDING TO THE REPORTER, ON (B)(6) 2025, DURING A HEMODIALYSIS SESSION, THE HOSPITAL STAFF DETECTED BLEEDING AT THE CONNECTION SITE OF THE CHRONIC CATHETER. AFTER DISCONNECTING THE PATIENT, THE NURSE OBSERVED A CRACK IN THE SPIRAL CAP (BLUE LUER ADAPTER). TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. FOLLOWING COMMUNICATION WITH THE PATIENT'S FAMILY, THE CATHETER WAS REPAIRED BY REPLACING THE BLUE LUER ADAPTER AS A REMEDIAL ACTION AND THE INTERVENTION/TREATMENT REQUIRED AS A RESULT 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 23484992 ↗
• MalfunctionAug 20, 2025Break; Defective Component; Break; Defective Component

  ACCORDING TO THE REPORTER, DURING PRE-OP, THE BLUE LUER ADAPTER/INTERFACE DID NOT MATCH THE SYRINGE. THE SPECIFIC ISSUE REPORTED AND THE OTHER DEFECT OR DAMAGE FOUND ON THE PRODUCT WAS THAT THE LUER CONNECTORS WERE ROUNDED AND COULD NOT BE ADAPTED TO ALL PORTS. THE CATHETER WAS NOT REPAIRED. NO OTHER PROBLEMS WERE REPORTED WITH THE ADAPTER ASIDE FROM WHAT WAS ALREADY REPORTED. ASIDE FROM THE REPORTED ISSUE, NOTHING ELSE UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE SYRINGE INCLUDED IN THE KIT WAS TO BE THE ONE USED. THE REMEDIAL ACTION PERFORMED TO ADDRESS THE ISSUE WAS REPLACING IT WITH A NEW CATHETER ON THE SAME DAY WITH THE SAME PRODUCT (IDENTIFIER) AND SAME LOT, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE LUER ADAPTER WAS CRACKED, LEAKING, OR BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22856354 ↗
• MalfunctionJul 16, 2025Break; Break

  ACCORDING TO THE REPORTER, BEFORE PREPARING FOR DIALYSIS, A CONNECTOR BREAKAGE (CRACKED) WAS OBSERVED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WAS NO LEAK. 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. FLUSHING WAS DONE, AND THE RESULT WAS A CRACKED CONNECTOR OBSERVED BEFORE CONNECTION. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE CATHETER WAS REPAIRED. THE PROCEDURE WAS COMPLETED AFTER THE REMEDIAL ACTION WAS PERFORMED. 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 22524620 ↗
• MalfunctionJul 10, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING TREATMENT, WHEN CONNECTING THE AV (ARTERIOVENOUS) LINE CONNECTION, A CRACK WAS FOUND IN THE LUER CONNECTOR. IT WAS ALSO STATED THAT THERE WAS A LEAK AT THE LUER ADAPTER. THE CATHETER WAS NOT REPAIRED. THE CLEANING AGENT USED IN THE DEVICE WAS ALCOHOL-FREE IODOPHORS. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470292 ↗
• InjuryJul 9, 2025Insufficient Flow or Under Infusion; Material Deformation; Insufficient Flow or Under Infusion; Material Deformation

  ACCORDING TO THE REPORTER, THE FLOW RATE WAS NORMAL AFTER THE PRODUCT WAS IMPLANTED. THE CATHETER WAS DISCOUNTED (KINKED) THE DAY AFTER THE SURGERY, AND BLOOD COULD NOT BE DRAWN. A DIAGNOSTIC IMAGING WAS PERFORMED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. IODINE VAPORS ARE ALCOHOL-FREE; THEY WERE THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 22464849 ↗
• MalfunctionJul 7, 2025Break; Insufficient Flow or Under Infusion; Break; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, THE PATIENT EXPERIENCED INADEQUATE BLOOD FLOW DURING LONG-TERM CHRONIC CATHETER DIALYSIS AND WAS DISCONNECTED AFTER BLOOD RETURN. WHEN THE CATHETER WAS SEALED WITH UROKINASE, A CRACK WAS OBSERVED AT THE VENOUS END OF THE CATHETER'S SPIRAL CONNECTOR. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS REPAIRED, BUT THE REPAIR KIT WAS NOT USED. 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. THE CLEANING WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING THE OINTMENT TO THE AREA. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. AFTER LOCAL DISINFECTION OF THE CENTRAL VENOUS CATHETER IN THE TREATMENT ROOM, THE VENOUS SPIRAL CONNECTOR WAS REPLACED AS A REMEDIAL ACTION AND THE INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE PATIENT WAS THEN RETURNED TO THE DIALYSIS ROOM FOR BLOOD DRAINAGE AND RECONNECTED TO THE DIALYSIS MACHINE. BLOOD FLOW WAS SUCCESSFULLY RESTORED, AND THE DIALYS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22420445 ↗
• MalfunctionJul 2, 2025Break; Break

  ACCORDING TO THE REPORTER, BEFORE USING THE DIALYSIS TREATMENT, A CRACK WAS FOUND IN THE ARTERIAL CONNECTOR (RED). IT WAS ALSO MENTIONED THAT THERE WAS A LEAK AT THE LUER ADAPTER; IT OCCURRED AT THE SAME LOCATION WHERE THE CRACK WAS FOUND. THE LEAK WAS NOT OBSERVED DURING INSPECTION. 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. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. TEGO WAS UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. 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 CONNECTOR. THE PROCEDURE WAS COMPLETED AFTER THE REMEDIAL ACTION. 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 22391077 ↗
• MalfunctionJul 2, 2025Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  ACCORDING TO THE REPORTER, BEFORE PREPARING FOR DIALYSIS, IT WAS FOUND THAT THE CATHETER HAD A CRACK AT THE BLUE (VENOUS) CONNECTOR. IT WAS ALSO STATED THAT THE CATHETER HAD A LEAK AT THE LUER CONNECTOR. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE ASIDE FROM THE ISSUE. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. FLUSHING WAS DONE PRIOR TO USE, AND CRACKS IN THE CONNECTOR WERE OBSERVED, SO FLUSHING WAS STOPPED. THE CLEANING AGENT USED ON THE DEVICE WAS IODOPHOR. 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. THE CLEANING AGENT THAT WAS TYPICALLY UTILIZED TO CLEAN THE ADAPTER WAS IODOPHOR. THE METHOD UTILIZED TO TIGHTEN THE ADAPTER WAS BY HAND. 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 INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. AS A REMEDIAL ACTION, THE CATHETER WAS REPAIRED BY REPLACING THE DOMESTIC TEMPORARY CATHETER CONNECTOR. THE KIT WAS NOT USED. THE TREATMENT PROCEEDED AND WAS COMPLETED AFTER THE REMEDI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391071 ↗
• MalfunctionJul 1, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A RIGHT INTERNAL JUGULAR VEIN LONG-TERM CATHETER PLACEMENT ON (B)(6) 2025, DUE TO HYPOPROTEINEMIA AND HEART FAILURE. ON THE DAY OF THE EVENT, A CRACK WAS DETECTED IN THE EXTERNAL CONNECTOR OF THE CATHETER VENOUS (BLUE), WHICH COULD LEAD TO BLOOD LEAKAGE, FLUID LEAKAGE, AND INFECTION. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO EXCESSIVE FORCED USE ON THE DEVICE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE CLEANING AGENT(S) ARE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. THE INTERVENTION REQUIRED THE EXTERNAL CONNECTOR TO BE REPLACED BEFORE DIALYSIS COULD BE CONTINUED, THEREBY INCREASING THE RISK OF INFECTION AND IMPOSING ADDITIONAL FINANCIAL BURDEN ON THE PATIENT. 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 22368367 ↗
• MalfunctionJun 23, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A SEMI-PERMANENT RIGHT INTERNAL JUGULAR DIALYSIS CATHETER PLACEMENT DUE TO UREMIA. ON THE DAY OF THE EVENT, A CRACK WAS DETECTED IN THE EXTERNAL CONNECTOR/LUER ADAPTER OF THE CATHETER, RESULTING IN SPILL LEAKAGE OF FLUID AND BLOOD. A TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CATHETER HAD BEEN IN PLACE FOR 3 MONTHS AND 25 DAYS WHEN THE CRACK WAS OBSERVED. 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 PATIENT REQUIRED THE REPLACEMENT OF THE LONG-TERM EXTERNAL CATHETER CONNECTOR TO CONTINUE DIALYSIS NORMALLY, AND ONLY THE CONNECTOR WAS REPLACED TO ADDRESS THE ISSUE. THE PATIENT DID NOT HAVE AN INFECTION DUE TO THE EVENT. THE AMOUNT OF BLOOD LOST (ML) AS A RESULT OF THE EVENT WAS UNSPECIFIED. BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INDICATION THAT THE PATIENT WAS IN IMMEDIATE DANGER OR HAD LIFE-THREATENING COMPLICATIONS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307339 ↗
• MalfunctionJun 17, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT THE PLACEMENT OF A SEMI-PERMANENT RIGHT INTERNAL JUGULAR VEIN DIALYSIS CATHETER ON (B)(6) 2024 AND CONTINUED WITH REGULAR HEMODIALYSIS TREATMENTS. ON THE DAY OF THE EVENT, A CRACK WAS OBSERVED IN THE CATHETER'S EXTERNAL VENOUS (BLUE) CONNECTOR, WHICH COULD POTENTIALLY LEAD TO BLEEDING, FLUID LEAKAGE, AND INFECTION. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE WITH NORMAL RESULTS. NO EXCESSIVE FORCED USE ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CLEANING AGENT(S) ARE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. THE EXTERNAL CONNECTOR WAS REPLACED, AND DIALYSIS THERAPY WAS RESUMED. AS A REMEDIAL ACTION, THE CATHETER WAS REPAIRED. THE PROCEDURE WAS CONTINUED AND COMPLETED AFTER THE REMEDIAL ACTION WAS PERFORMED. BESIDES THE REP ORTED 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. THE INTERVENTION/TREATMENT WAS REPLACING THE EXTERNAL CONNECTOR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22256992 ↗
• MalfunctionJun 10, 2025Break; Insufficient Flow or Under Infusion; Break; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, THE PATIENT HAD INSUFFICIENT BLOOD FLOW DURING DIALYSIS WITH A LONG-TERM CENTRAL VENOUS CATHETER AND WAS TAKEN OFF THE DIALYSIS DEVICE. WHEN THE CATHETER WAS SEALED WITH UROKINASE, IT WAS FOUND THAT THE SCREW OF THE VENOUS END OF THE CATHETER WAS CRACKED. AFTER LOCAL DISINFECTION OF THE CENTRAL VENOUS CATHETER IN THE TREATMENT ROOM, THE SCREW OF THE VENOUS END WAS REPLACED AGAIN. THE PATIENT RETURNED TO THE DIALYSIS ROOM TO DRAW BLOOD AGAIN AND WAS PUT ON THE DIALYSIS DEVICE. THE BLOOD FLOW WAS RESTORED, AND THE DIALYSIS PROCESS WENT SMOOTHLY. THE CATHETER WAS REPAIRED. THERE WAS NO LEAK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177553 ↗
• MalfunctionJun 9, 2025Break; Break

  ACCORDING TO THE REPORTER, FOLLOWING ROUTINE DISINFECTION, HEMODIALYSIS WAS INITIATED VIA THE DIALYSIS TUBING. DURING USE, CONTINUOUS AIR BUBBLES WERE OBSERVED ENTERING THE ARTERIAL END OF THE TUBING/LUER ADAPTER. UPON REVERSAL FOR BLOOD RETURN, THERE WAS EVIDENCE OF BLOOD LEAKAGE/WEEPING LOCATED AT THE ARTERIAL END OF THE TUBING. THE CATHETER WAS NOT REPAIRED. A TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE INITIAL DISPOSITION WAS TO STOP USING THE CATHETER/TUBING AND REPLACE THE CENTRAL VENOUS CATHETER SET WITH A NEW CHRONIC CATHETER FROM THE SAME BRAND, AND THE TREATMENT WAS COMPLETED. THE EVENT DID NOT CAUSE DIALYSIS FAILURE. THERE WAS AN UNSPECIFIED AMOUNT OF BLOOD LOSS. A BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166308 ↗
• MalfunctionJun 4, 2025Material Fragmentation; Product Quality Problem; Material Fragmentation; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING THE OPERATION, IT WAS FOUND THAT THE SHELL WAS TORN, MEANING THE DISTAL POSITION OF THE AVULSION SHEATH WAS DISTORTED AND DEFORMED, AND THE LONG-TERM TUBE COULD NOT BE INSERTED INTO THE BLOOD VESSEL. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. WE DID NOT USE ANY CLEANING AGENT ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. AS A REMEDIAL ACTION, THE TUBING WAS REPLACED, AND THE PROCEDURE WAS ABLE TO PROCEED AND COMPLETE. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO EXCESSIVE FORCE WAS USED ON THE DEVICE. NO INTERVENTION/TREATMENT WAS 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 22140987 ↗
• MalfunctionJun 2, 2025Break; Insufficient Flow or Under Infusion; Break; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT AT 18:00 IN THE HEMODIALYSIS UNIT OF THE HOSPITAL, THE RESPONSIBLE NURSE FOLLOWED THE STANDARD OPERATING PROCEDURE TO OPEN THE CENTRAL VENOUS CATHETER FOR A PATIENT. UPON INSPECTION, THE GAUZE COVERING THE EXPOSED PART OF THE CATHETER WAS FOUND TO BE INTACT. WHEN THE TUBE WAS OPENED TO DRAW THE ARTERIAL LINE SEALING SOLUTION, SOME AIR BUBBLES APPEARED IN THE SYRINGE. DURING THE BLOOD DRAW PROCESS, A LARGE AMOUNT OF AIR WAS OBSERVED IN THE BLOOD FLOWING OUT OF THE ARTERIAL LINE. THE CONNECTION OF THE EXTRACORPOREAL CIRCULATION PIPELINE WAS CHECKED TO BE INTACT. THE BLOOD PUMP WAS IMMEDIATELY STOPPED, AND THE CENTRAL VENOUS CATHETER WAS CHECKED. A RUPTURE WAS FOUND 2 CM BELOW THE Y-CONNECTOR OF THE CATHETER. A LEAK WAS OBSERVED AT THE BIFURCATE. THE DOCTOR WAS INFORMED, AND THE CATHETER WAS SEALED ACCORDING TO MEDICAL ADVICE, WITH DIALYSIS TREATMENT BEING DISCONTINUED. THE HOSPITAL WAS UNABLE TO REPLACE THE CENTRAL VENOUS CATHETER; THE PATIENT WAS INFORMED TO TRANSFER TO A HIGHER-LEVEL HOSPITAL TO REPLACE THE CENTRAL VENOUS CATHETER FOR HEMODIALYSIS TREATMENT. THE CATHETER WAS NOT REPAIRED. THE TEGO WAS NOT UTILIZED. THERE WAS NO LUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128081 ↗
• MalfunctionJun 2, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING USE, A CRACK WAS DISCOVERED IN THE ARTERIAL INTERFACE OF THE CHRONIC CATHETER. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. FLUSHING WAS DONE, AND THE RESULT WAS NORMAL. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO CONCOMITANT MEDICATION/DEVICE. THE ADAPTERS ARE TIGHTENED MANUALLY BY HAND. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. BESIDES THE REPORTED ISSUE, THERE WERE NO VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. AS A REMEDIAL ACTION, THE CATHETER WAS REPLACED WITH A DIFFERENT PRODUCT ID AND LOT NUMBER. THE PROCEDURE WAS COMPLETED AFTER THE REMEDIAL ACTION. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127873 ↗
• MalfunctionMay 22, 2025Break; Break

  ACCORDING TO THE REPORTER, ONE WEEK AFTER CATHETER IMPLANTATION, IT WAS FOUND THAT THE LUER CONNECTOR AT THE BLUE (VENOUS) END HAD OBVIOUS CRACKS AND LEAKAGE OCCURRED. THERE WAS NOTHING UNUSUAL 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. FLUSHING WAS DONE WITH NORMAL RESULTS. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. IODOPHOR (WITHOUT ALCOHOL) 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 TO THE AREA. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT, AND TEGO WAS NOT UTILIZED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE ADAPTER ISSUE AND AS A RESULT OF THE EVENT. AS A REMEDIAL ACTION, THE CATHETER WAS REPAIRED BY REPLACING THE LUER CONNECTOR USING THE REPAIR KIT. THE TREATMENT CONTINUED 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 problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075674 ↗
• MalfunctionMay 20, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING TREATMENT AFTER CATHETER IMPLANTATION, AN ARTERIAL PRESSURE ALARM OCCURRED, AND AN OBVIOUS SPLIT AND CRACK WERE OBSERVED IN THE RED LUER ADAPTER. THERE WAS A LEAK AT THE LUER ADAPTER. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. THE TYPE OF CLEANING AGENT USED ON THE DEVICE WAS IODOPHOR (WITHOUT ALCOHOL). A TEGO WAS NOT UTILIZED. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057645 ↗
• InjuryApr 21, 2025Protective Measures Problem; Protective Measures Problem

  ACCORDING TO THE REPORTER, THE PATIENT, A UREMIC INDIVIDUAL REQUIRING LONG-TERM HEMODIALYSIS (HD), UNDERWENT SEMI-PERMANENT CATHETER PLACEMENT IN THE RIGHT INTERNAL JUGULAR VEIN AFTER ESTABLISHING LONG-TERM VASCULAR ACCESS. DURING THE PROCEDURE, AFTER PLACING THE CATHETER THROUGH THE PEEL-AWAY SHEATH AND REMOVING THE SHEATH, THE REFLUX VALVE BECAME BLOCKED WHEN PUSHED BACK, AS THE PEEL-AWAY SHEATH CHECK VALVE COULD NOT BE COMPLETELY CLOSED. FLUSHING WAS DONE PRIOR TO USE. NO OTHER PRODUCTS WERE USED WITH THE DEVICE, NO CLEANING AGENT WAS USED, AND TEGO WAS NOT UTILIZED. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. THE ISSUE WAS ADDRESSED BY THE RAPID IMPLANTATION OF THE PEEL-AWAY SHEATH, RAPID SHEATH CORE REMOVAL, AND CATHETER IMPLANTATION. AFTER THE OPERATION, WHEN THE PATIENT STOOD UP, THE CATHETER HAD BEEN PLACED FOR 5 MINUTES WHEN SYMPTOMS SUCH AS SLOW REACTION, YAWNING, CHOKING, UNRESPONSIVENESS, AND A SIGNIFICANT DROP IN BLOOD OXYGEN SATURATION TO 54% WERE OBSERVED, WHICH WAS CONFIRMED AS AN AIR EMBOLISM. IN RESPONSE, THE PATIENT WAS IMMEDIATELY GIVEN OXYGEN, PLACED IN THE LEFT LATERAL DECUBITUS POSITION, AND ELECTROCARDIOGRAM (ECG) MONITORING WAS INITIATED. THE PAT

  Patient problems: Air Embolism; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Choking; Cough; Hyperglycemia; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 21873234 ↗
• MalfunctionMar 17, 2025Break; Break

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, IT WAS FOUND THAT THE VENOUS CATHETER PORT WAS OOZING BLOOD WHEN THE PATIENT WAS CONNECTED TO THE MACHINE. THE VENOUS END WAS IMMEDIATELY REMOVED, AND THE CRACK WAS FOUND AT THE BLUE END ADAPTER. THE CONNECTION WAS REVERSED IMMEDIATELY, AND THE PATIENT WAS CONNECTED TO THE MACHINE NORMALLY. SIXTEEN DAYS AFTER THE DAY OF THE EVENT, THE CATHETER WAS REPLACED WITH A DIALYSIS CATHETER CONNECTION ADAPTER WITH A TUNNEL POLYESTER SLEEVE, WHICH WAS IN NORMAL USE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21618868 ↗
• MalfunctionMar 14, 2025Break; Break

  ACCORDING TO THE REPORTER, ONE MONTH AFTER THE CATHETER WAS IMPLANTED, OOZING BLOOD WAS OBSERVED DURING HEMODIALYSIS WHEN THE MACHINE WAS CONNECTED. THE RED (ARTERIAL) LUER ADAPTER HAD A CRACK (RUPTURE) AND WAS LEAKING. THE INSERTION SITE WAS TREATED PRIOR TO THE PLACEMENT OF THE DEVICE. NO INSTRUMENTS WERE USED TO LOOSEN OR TIGHTEN THE DEVICE. TEGO WAS NOT UTILIZED. BETADINE WAS THE CLEANING AGENT USED FOR CLEANING THE ADAPTERS, WHILE IODOPHOR WAS THE CLEANING AGENT USED FOR CLEANING THE DEVICE. NO ABNORMALITIES WERE FOUND ON THE DEVICE PRIOR TO USE, AND NO OTHER DEFECTS OR DAMAGES WERE OBSERVED ON THE PRODUCT AT THE TIME OF THE EVENT. FLUSHING WAS PERFORMED WITH NORMAL RESULTS. THE EXTRACORPOREAL CIRCUIT WAS THE OTHER PRODUCT USED WITH THE DEVICE. NO EXCESSIVE FORCE WAS APPLIED. THE CATHETER WAS REPAIRED AS A REMEDIAL ACTION, AND THE DEFECTIVE HEAD COULD NOT BE RETURNED BECAUSE THE CUSTOMER REFUSED TO RETURN IT. A SERVICE KIT WAS USED WITH A PRODUCT OF A DIFFERENT PRODUCT ID. THE TREATMENT WAS COMPLETED, AND NO MEDICAL INTERVENTION OR TR EATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS A 1 MILLILITER BLOOD LOSS, BUT A BLOOD TRANSFUSION WAS NOT PERFORMED. THERE WAS NO REPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21605161 ↗
• MalfunctionMar 3, 2025Break; Break

  ACCORDING TO THE REPORTER, WHEN THE MACHINE WAS CONNECTED, A BLOOD LEAK WAS FOUND AT THE PATIENT'S INTRAVENOUS CATHETER CONNECTOR. THE HEAD NURSE WAS IMMEDIATELY INFORMED, AND THE DIRECTOR WAS NOTIFIED. THE DIRECTOR REMOVED THE INTRAVENOUS END AND FOUND A CRACK. THE CATHETER WAS IMMEDIATELY CONNECTED TO THE MACHINE NORMALLY IN REVERSE CONNECTION, AND THEY PAID ATTENTION OR CLOSE OBSERVATION TO WHETHER THERE WAS BLOOD LEAKAGE AND LIQUID LEAKAGE AT THE CATHETER CONNECTOR IN THE FUTURE AS PRELIMINARY ACTIONS. ON JANUARY 24TH, THE VENOUS CONNECTOR AT THE DIALYSIS CATHETER WAS REPLACED WITH A TUNNEL POLYESTER SHEATH, AND IT WAS USED NORMALLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21507022 ↗
• MalfunctionMar 3, 2025Break; Break

  ACCORDING TO THE REPORTER, ON (B)(6) 2024, THE PATIENT UNDERWENT LONG-TERM CATHETERIZATION OF THE RIGHT INTERNAL JUGULAR VEIN IN THE HOSPITAL, AND THEN MAINTAINED HEMODIALYSIS TREATMENT. ON (B)(6) 2025, THE PATIENT CAME TO THE HOSPITAL FOR HEMODIALYSIS TREATMENT. THE PATIENT¿S LONG-TERM CATHETER WAS EXAMINED BEFORE GOING ON THE MACHINE, AND IT WAS FOUND THE VENOUS CATHETER LUER ADAPTER WAS BROKEN. AFTER THE REPORTED PRODUCT WAS REPLACED, THE TREATMENT WENT SMOOTHLY AND THE PATIENT UNDERWENT DIALYSIS NORMALLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21506804 ↗

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-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.