Palindrome 8888145017Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10884521013193), received between Feb 13, 2018 and Aug 15, 2025 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

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

2 other recalls cover devices cleared under the same FDA submission (K111372); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 8, 2022Class IOpen, Classified

   There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

   Z-1316-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Break; Material Puncture/Hole; Break; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING PRE-FLUSHING, HOLES AND LEAKAGE WERE FOUND AT THE EXTERNAL EXTENSION TUBE NEAR THE ARTERIAL LUER ADAPTER. THE PRODUCT WAS NOT USED, AND THE CATHETER WAS NOT REPAIRED. NOTHING ELSE UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, AND NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. THE CATHETER WAS REPLACED ON THE SAME DAY WITH THE SAME PRODUCT ID (IDENTIFIER) AND LOT NUMBER TO ADDRESS THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814770 ↗
• MalfunctionMay 7, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING THE OPERATION, WHEN THE SURGEON WAS OPERATING THE TUNNEL NEEDLE, THE PLASTIC ACCESSORIES OF THE TUNNEL NEEDLE WERE BROKEN, AND THE OPERATION COULD NOT BE COMPLETED NORMALLY. THERE WAS A LEAK. THE CATHETER WAS NOT REPAIRED, AND NO TEGO WAS UTILIZED. THERE WAS NO ISSUE WITH THE LUER ADAPTER. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NO CLEANING AGENT WAS USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21980771 ↗
• MalfunctionOct 9, 2024Migration; Migration

  ACCORDING TO THE REPORTER, THE CATHETER WAS IMPLANTED IN THE PATIENT ONE MONTH AGO, AND BEFORE DIALYSIS, AT THE TIME WHEN DIALYSIS WAS GOING TO START, IN CHARGE OF FLUSHING THE CATHETER, THE CATHETER CAME OUT DUE TO FLUSHING WITH HEPARIN. AS THE HCP (HEALTH CARE PROFESSIONAL) SUGGESTED, THERE WAS NO FIBROSIS FORMED TO HOLD THE CATHETER IN THE PATIENT'S BODY. THE CATHETER WAS NOT REPAIRED; THERE WAS NO LEAK, AND NORMAL SALINE AND HEPARIN WERE THE CLEANING AGENTS USED ON THE DEVICE. TEGO WAS UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED WITH BETADINE SOLUTION PRIOR TO PRODUCT PLACEMENT. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. THE PRODUCT WAS REPLACED WITH ANOTHER CATHETER FROM THE SAME LOT THE NEXT DAY AS AN ACTION TO RESOLVE THE ISSUE, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. NO MEDICAL INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407597 ↗
• MalfunctionMay 24, 2024Break; Break

  ACCORDING TO THE REPORTER, THE LUER ADAPTOR OF VENOUS (BLUE) CRACKED, AND A SMALL, TINY HOLE WAS OBSERVED IN IT. THERE WAS A LEAK AT THE LOCATION OF THE LEAK. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. THE CATHETER WAS NOT REPAIRED. NORMAL SALINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE TREATED PRIOR TO PRODUCT PLACEMENT. THE PRODUCT WAS REPLACED WITH THE SAME LOT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19395431 ↗
• MalfunctionMay 20, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, AFTER THE PATIENT HAD A CATHETER INSERTED ON (B)(6) 2024, THE PATIENT UNDERWENT DIALYSIS THREE TIMES A WEEK. AFTER THE CATHETER HAD BEEN USED FOR ONE MONTH, WHEN VIGOROUSLY PUMPING AND PUSHING THE CATHETER (WHICH MEANT BY USE A SYRINGE TO CONNECT THE CATHETER CONNECTOR TO ASPIRATE AND INJECT BLOOD IN ORDER TO CHECK WHETHER THERE WAS THROMBUS IN THE CATHETER AND TO TEST THE PATENCY OF THE CATHETER) BEFORE GETTING ON THE MACHINE ON FEBRUARY 27, FOUND THAT THERE WAS SPOTTY OOZING BLOOD AT THE RED CATHETER PORT AND THERE MIGHT BE A SAND-HOLE THAT WAS INVISIBLE TO THE NAKED EYE, RESULTING TO THIS OOZING BLOOD. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THEY IMMEDIATELY STOPPED USING THE CATHETER. RE-CATHETERIZATION WAS PERFORMED, THE PRODUCT WAS REPLACED WITH THE SAME ID (IDENTIFIER) AND CONTINUED THE TREATMENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19353939 ↗
• MalfunctionMar 18, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, RIGHT FEMORAL VEIN CATHETERIZATION WAS PERFORMED ON (B)(6) 2024, AND NO PROBLEMS WERE FOUND WITH THE USE OF THE CATHETER FOR CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY) TREATMENT. DURING NORMAL USE, WHEN THE DOCTOR TESTED THE CATHETER FLOW ON (B)(6) 2024, THEY FOUND THAT THERE WAS BLEEDING NEAR THE BIFURCATION OF THE EPITAXIAL CATHETER, SUSPECTED OF A HOLE. THE JUNCTION OF THE EXTENSION TUBE AND THE BIFURCATE WAS THE LOCATION OF THE LEAK. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED WITH IODOPHOR PRIOR TO PRODUCT PLACEMENT. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE, AND IT WAS TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. THE CLAMP WAS MOVED PERIODICALLY. FLUSHING WAS DONE PRIOR TO USE, AND THE RESULT HAD NO PROBLEMS. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS OR DAMAGE WERE FOUND ON THE PRODUCT. THE INSERTION SITE WAS TREATED WITH IODOPHOR PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS REPLACED WITH THE SAME PRODUCT ID (IDENTIF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18927295 ↗
• MalfunctionAug 18, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, AFTER CATHETERIZATION WAS COMPLETED, THE CATHETER HAD A BLOOD LEAK AND A HOLE AT THE EXTENSION TUBE NEAR THE VENOUS LUER ADAPTER. THE CATHETER WAS NOT REPAIRED AND WAS DISASSEMBLED FOR IMMEDIATE TRIAL. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE WITH NORMAL RESULT. THERE WAS NO LUER ADAPTER ISSUE. TEGO WAS NOT UTILIZED. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. AN ALCOHOL-BASED CLEANER WAS USED FOR FINAL DISINFECTION OF THE DEVICE. THERE WAS NO EXCESSIVE FORCE APPLIED ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED BEFORE THE PRODUCT WAS IMPLANTED. THERE WAS NO PRESCRIBED OR OVER-THE-COUNTER OINTMENT USED ON THE EXIT SITE. THE CLEANING AGENT WAS NOT ALLOWED TO BE DRIED THOROUGHLY PRIOR TO DRESSING THE AREA. THE CLEANING AGENTS WERE NOT MIXED AND WERE NEVER SWITCHED OVER THE LIFE OF THE CATHETER. A GAUZE WAS USED AS A WO UND DRESSING, AND IT DID NOT CONTAIN ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES. THE SITE DID NOT USE SEPSIDERM TO CLEAN THE CATHETER. THERE WAS NO RECENT PROTOCOL CHANGE FOR THE CLEANING AGENTS USED. THE PATIENT DID NOT USE ANY TYPE OF CLEANING AGENT OR ANTIBIOTIC ON TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17577338 ↗
• MalfunctionJul 26, 2023Misassembled; Product Quality Problem; Misassembled; Product Quality Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE AND BEFORE THE SURGERY, THE PATIENT HAD KIDNEY FAILURE REQUIRING DIALYSIS. IT WAS STATED THAT THERE WAS MISSING PUNCTURE NEEDLE ON THE PRODUCT. THERE WAS NO LEAK, NO PROBLEM WITH THE LUER ADAPTER, AND THE CATHETER WAS NOT REPAIRED. FLUSHING WAS NOT DONE PRIOR TO USE. THERE WERE NO DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WERE NO PRODUCTS BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO CLEANING AGENT WAS USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED WITH POVIDONE IODINE WIPE PRIOR TO PRODUCT IMPLANTATION. A NEW CATHETER WAS REOPENED TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397797 ↗
• MalfunctionJun 2, 2023Migration; Migration

  ACCORDING TO THE REPORTER, DURING NORMAL USE, THE CATHETER CUFF DISPLACED FROM THE LOCATION. THERE WAS NO LEAK, NO LUER ADAPTER ISSUE, AND THE CATHETER WAS NOT REPAIRED. NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WAS NO INSERTION SITE TREATED PRIOR TO PRODUCT PLACEMENT. TEGO WAS NOT UTILIZED. POVIDONE IODINE WAS USED AS CLEANING AGENT ON TO THE DEVICE. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE ISSUE WAS OBSERVED, NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. FLUSHING WAS DONE PRIOR TO USE WITH NORMAL RESULT. THE CATHETER WAS REMOVED AND REPLACED WITH THE SAME BATCH AND LOT NUMBER AS REMEDIAL ACTION PERFORMED, AND TREATMENT WAS PROCEEDED AND COMPLETED AFTER REPLACEMENT. CATHETER EXCHANGE WAS DONE AS INTERVENTION/TREATMENT. 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 17053314 ↗
• MalfunctionJan 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, TWO DAYS AFTER THE CATHETER KIT WAS IMPLEMENTED, THE BLUE PART SEPARATED FROM THE TRANSPARENT LINE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16131593 ↗
• MalfunctionDec 6, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING NORMAL USE, THE PRODUCT WAS INTENDED FOR COLLECTION THAT WAS USED ON THE PATIENT (RECALL FA122). THE PATIENT WAS DOING WELL AND WAS BEING MONITORED BY THE MEDICAL TEAM. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATION ASSOCIATED WITH THIS EVENT AND 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 REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15927162 ↗
• MalfunctionNov 29, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, IT WAS FOUND THAT AN EXPIRED CATHETER WAS USED ON THE PATIENT. IT WAS STATED THAT THE PRODUCT WAS SHORT DATED/EXPIRED STOCK. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, NO OTHER DEFECTS/DAMAGES WERE FOUND ON THE PRODUCT AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THE DEVICE WAS RECEIVED DIRECTLY FROM THE COMPANY'S DISTRIBUTOR (MIDRAND). IT WAS STATED THAT ANOTHER PRODUCT WAS USED TO RESOLVE THE ISSUE AND TREATMENT WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15877362 ↗
• InjuryOct 27, 2022Insufficient Flow or Under Infusion; Defective Component; Insufficient Flow or Under Infusion; Defective Component

  ACCORDING TO THE REPORTER, HD (HEMODIALYSIS) STARTED WITH GOOD FLOWS FROM CVC (CENTRAL VENOUS CATHETER) THEN AFTER ABOUT 30 MINUTES, VENOUS PRESSURES INCREASED. THE LINE WAS CONNECTED TO SYRINGE AND LARGE CLOTS AND FIBRIN WERE REMOVED AND THIS COULD BE REPEATED SEVERAL TIMES DURING TREATMENT. THIS LOT WAS ONE OF THE AFFECTED LOTS OF RECALL (FA1244). THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THE PATIENT WAS WASHED BACK AND TPA (TISSUE PLASMINOGEN ACTIVATOR) OR 7 UNITS OF UROKINASE PUSH PAULSE, 5 UNITS OF UROKINASE LOCK, 11 UNITS OF ACTILYS WERE INSTILLED AND THEN TREATMENT CONTINUED. THE PATIENT STARTED APIXABAN DUE TO LINE ISSUES. IT WAS ALSO STATED THAT WHEN THE ACCESS WAS BEING FLUSHED OR WORKED WITH, THE PATIENT WAS GENERALLY HAD TO BE WASHBACK OTHERWISE THE PATIENT HAS A REDMAN SYNDROME AFFECT AND REQUIRES O2 (OXYGEN), ONCE THIS HAPPENS THE PATIENT THEN DROPS HIS BP (BLOOD PRESSURE) AND BECOMES TA CHYCARDIC. THEY WERE AWAITING FOR LINE REMOVAL.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15681778 ↗
• MalfunctionSep 6, 2022Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE CATHETER SHOWED RESISTANCE AT INSERTION. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. 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 REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15365238 ↗
• MalfunctionOct 7, 2021Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, PRE-OPERATIVE FLUSHING OF THE CATHETER, SOME OBSTRUCTION WAS OBSERVED IN THE ARTERIAL LUMEN. BOTH LUMENS WERE FLUSHED, THE VENOUS LUMEN DID NOT HAVE ANY ISSUES AND FLUSHING WAS NOT SUCCESSFULLY DONE IN ARTERIAL LUMEN. A NEW CATHETER KIT WAS OPENED. AFTER THE SUCCESSFUL FLUSHING OF THE NEW CATHETER, IT WAS SUCCESSFULLY INSERTED TO THE PATIENT AND SUBSEQUENT DIALYSIS WAS COMPLETED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE, THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT, THERE WAS NO DAMAGE TO THE DEVICE'S EXTERNAL PACKAGING AND BOX. BETADINE WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT AND THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, BETADINE AND CHLORHEXIDINE WAS USED AS THE CLEANING AGENT ON THE DEVICE. TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE AND 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 12590790 ↗
• MalfunctionJan 29, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING DIALYSIS SESSION, LEAKAGE WAS OBSERVED FROM THE CUT AT JUNCTION OF ARTERIAL EXTENSION TUBE AND BIFURCATE. THE CLAMP WAS MOVED PERIODICALLY. NOTHING UNUSUAL OBSERVED PRIOR TO USE. FLUSHING WAS DONE SUCCESSFULLY. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO DAMAGE TO THE DEVICE¿S BOX OR PACKAGING. THE PRODUCT WAS STILL SEALED UPON RECEIPT. BETADINE WAS THE CLEANING AGENT USED ON THE DEVICE AND IT WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. CHLORHEXIDINE WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. THE CLEANING AGENTS WERE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THE CATHETER WAS NOT REPAIRED, NO TEGO UTILIZED, AND NO LUER ADAPTER ISSUE. THERE WAS 5ML OF BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. NO OTHER INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE LEAKAGE. NO MEDICAL INTERVENTION REQUIRED TO THE PATIENT. THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER PRODUCT WITH THE SAME TYPE ON THE SAME DAY. THE DIALYSIS WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11249888 ↗
• MalfunctionDec 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AFTER THE HEMODIALYSIS PROCEDURE, THEY CANNOT DISCONNECT THE CATHETER. IT WAS STATED THAT THE OUTER PART OF THE LUER ADAPTER WAS DETACHED, BUT THE INNER PART WAS STILL CONNECTED TO THE CATHETER, AS THEY CANNOT DISCONNECT, THEY USED THE ARTERIAL CLIP TO DISCONNECT THE CATHETER AND THE BLOODLINE BY BREAKING THE CONNECTION POINT. PATIENT NEEDED TO GO TO OPERATING ROOM TO HAVE A NEW CATHETER INSERTED. IT WAS ALSO STATED THAT AFTER DISCONNECTION, A CHIP WAS FOUND INSIDE THE DEVICE WHICH WAS FROM THE LUER ADAPTER. PURE HEPARIN WAS USED AS THE CLEANING AGENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8176114 ↗
• MalfunctionFeb 23, 2018Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, AFTER DIALYSIS HAD BEEN COMPLETED THE CUSTOMER NOTICED THE DEVICE HAD A LEAK IN THE MIDDLE OF THE SILICONE EXTENSION TUBE. THE CATHETER WAS REPLACED AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7291884 ↗
• MalfunctionFeb 21, 2018Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, THE MIDDLE OF THE EXTENSION TUBE WAS LEAKING. THE CATHETER WAS REPLACED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7286389 ↗
• MalfunctionFeb 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, THE MIDDLE OF THE EXTENSION TUBE WAS LEAKING. THE CATHETER WAS REPLACED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7267389 ↗
• MalfunctionFeb 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, THE MIDDLE OF THE EXTENSION TUBE WAS LEAKING. THE CATHETER WAS REPLACED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7267383 ↗
• MalfunctionFeb 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, THE MIDDLE OF THE EXTENSION TUBE WAS LEAKING. THE CATHETER WAS REPLACED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7266827 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111372. One submission often covers many models, so check the product and lot details in each record.

• Z-2632-2023 · Aug 22, 2023 · Open, Classified
  Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
• Z-1320-2022 · Jun 8, 2022 · Open, Classified
  Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.