Palindrome 8888145016Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10884521013179), received between Sep 29, 2017 and Apr 21, 2025 — classified as 1 death, 12 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (10 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Break; Leak/Splash; Break; Leak/Splash

  ACCORDING TO THE REPORTER, DURING NORMAL USE, THE CATHETER HAD LEAKAGE ON THE IMPLANT SIDE PART. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873315 ↗
• InjuryMar 3, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, DURING HEMODIALYSIS, THE CATHETER DID NOT PROVIDE ADEQUATE BLOOD FLOW, RESULTING IN INEFFECTIVE DIALYSIS. THE ISSUE WAS SYSTEMIC, WITH NO SPECIFIC LUMEN IDENTIFIED AS HAVING INADEQUATE FLOW. THERE WAS A LACK OF BLOOD RETURN, INDICATING DIFFICULTY WITH FLOW. THE LINE WAS DIFFICULT TO FLUSH WITH THE SYRINGE, AND NO BLOOD WAS RETURNED PRIOR TO FLUSHING. HOWEVER, FLUSHING WAS PERFORMED BEFORE USE, AND BLOOD RETURN WAS ACHIEVED IN THE PATHWAYS, DESPITE INITIAL DIFFICULTY. CHLORHEXIDINE WAS BEING USED ON THE TIPS BEFORE THE LINES WERE INSTALLED. TEGO WAS NOT USED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS/DAMAGES WERE FOUND IN THE PRODUCT. THE PATIENT DID NOT USE HEPARIN DURING THE DIALYSIS SESSION BUT USED INTRALUMINAL HEPARIN DURING THE INTERDIALYTIC PERIOD. THE PATIENT WAS ON ASPIRIN (ASA) AND CLOPIDOGREL FOR DUAL ANTIPLATELET THERAPY. NO OTHER PRODUCTS WERE BEING USED WITH THE DEVICE. THE CATHETER WAS IN USE FOR 92 DAYS. NO LEAKAGE WAS OBSERVED. THE REVERSE FLOW WAS NOT SUCCESSFUL. THE TREATMENT HAD A REDUCED TIME. MEDICAL INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT, WHICH INCLUDED EXTRA DIALYSIS SESSIONS AND

  Patient problems: Hyperkalemia; Swelling/ Edema

  MAUDE report 21505990 ↗
• InjuryMar 3, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, DURING HEMODIALYSIS, THE CATHETER DID NOT PROVIDE ADEQUATE BLOOD FLOW IN THE ARTERIAL LUMEN AND DIALYSATE WITH EFFICIENCY. THERE WAS A LACK OF BLOOD RETURN, INDICATING DIFFICULTY WITH FLOW. THE CATHETER WAS NOT DIFFICULT TO FLUSH WITH THE SYRINGE, AND BLOOD WAS RETURNED PRIOR TO FLUSHING. FLUSHING WAS PERFORMED, AND BLOOD RETURN WAS ACHIEVED THROUGH THE ROUTES. CHLORHEXIDINE HAD BEEN USED ON THE TIPS BEFORE THE LINES WERE INSTALLED. TEGO WAS NOT USED. NOTHING UNUSUAL HAD BEEN OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS OR DAMAGES WERE FOUND IN THE PRODUCT. NO OTHER PRODUCTS WERE BEING USED WITH THE DEVICE. THE DURATION OF CATHETER USE WAS 23 DAYS. THE PATIENT HAD NOT USED HEPARIN DURING THE DIALYSIS SESSION, THOUGH INTRALUMINAL HEPARIN HAD BEEN USED IN THE INTERDIALYTIC PERIOD. THE PATIENT HAD ALSO BEEN ON DUAL ANTIPLATELET THERAPY WITH ASPIRIN (AAS) AND CLOPIDOGREL. THE REVERSE FLOW WAS NOT SUCCESSFUL AS THE MOVEMENT OF BLOOD IN THE VENOUS WAS SLOWER. AFTER A SHORTER DIALYSIS SESSION, THE PATIENT PRESENTED WITH HYPERKALEMIA AND ACUTE EDEMA. THE CUSTOMER HAD EXCHANGED THE CATHETER WITH THE SAME LOT ON (B)(6) 2025, AND TREATMENT WAS COMPLETED WIT

  Patient problems: Hyperkalemia; Hypervolemia; Swelling/ Edema

  MAUDE report 21505971 ↗
• InjurySep 30, 2024Migration; Migration

  ACCORDING TO THE REPORTER, THE PATIENT HAD ANOTHER DISLODGEMENT TO ADD HIS FILE. THE CATHETER WAS A LEFT-SIDED SUBCLAVIAN (28 CM) INSERTED ON (B)(6) AND FOUND TO BE DISLODGED ON (B)(6). THE LINE HAD BEEN IN SITU FOR 22 DAYS; IT HAD BEEN USED TWICE SO FAR WITH A CUFF CLEARLY VISIBLE OUTSIDE OF THE PATIENT'S BODY. LINE REMAINED IN SITU DUE TO PATIENT'S HIGH POTASSIUM AND ACCESS NEEDED FOR DIALYSIS. THEY WERE STILL UNSURE OF THE AVAILABILITY OF INTERVENTIONAL RADIOLOGY SLOTS FOR REPLACEMENT. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Purulent Discharge; Unspecified Infection

  MAUDE report 20334078 ↗
• InjuryAug 23, 2024Migration; Migration

  ACCORDING TO THE REPORTER, THE PATIENT PRESENTED TO WARD 404 FOR THE USUAL DIALYSIS SESSION. PATIENT WAS GETTING CLEANED UP AFTER USING BEDPAN, PATIENT AND NURSING STAFF THOUGHT LINE MAY HAVE BEEN CAUGHT UP IN PATIENT¿S BRA. THE CUFF WAS DISPLACED, AND THE LINE SLID OUT A SIGNIFICANT DISTANCE. THE PATIENT REPORTS THAT SHE FELT NO PULLING OR TUGGING SENSATION AS THE LINE CAME OUT. THE NURSING STAFF APPLIED PRESSURE TO CONTROL THE BLEEDING AND REMOVED THE LINE AFTER A MEDICAL REVIEW. UNABLE TO WASH BACK, LINES CLOTTED, CIRCUIT LOST. THIS IS THE SECOND DISLODGEMENT FOR THE PATIENT. THE LINE WAS ASSOCIATED WITH THROMBUS AND STARTED ON APIXABAN. THE LINE HAD BEEN INSERTED ON (B)(6) 2024, SO IT HAD BEEN IN PLACE FOR 46 DAYS. THE SUTURES WERE REMOVED ON (B)(6) 2024. THE PATIENT AND NURSING STAFF THOUGHT LINE MAY HAVE BEEN A BIT TANGLED IN THE BRA AND TUGGED WHILE MOBILIZING. ONCE AGAIN, THE PATIENT SAID SHE FELT NO TUGGING OR PULLING SENSATION AS THE LINE CAME OUT; IT JUST SLID OUT. IT LOOKS LIKE THE CUFF HAS BARELY STARTED TO IMPLANT. IT LOOKS LIKE THE CUFF WAS NOT IMPLANTED AT ALL, DESPITE HAVING BEEN IN FOR SIX WEEKS. FLUSHING WAS DONE AND WAS ABLE TO START THE DIALYSIS AND HAVE A SESS

  Patient problems: Insufficient Information

  MAUDE report 20057436 ↗
• InjuryJul 23, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, A PATIENT WITH POLYCYSTIC KIDNEY DISEASE, HYPERTENSION, AND END-STAGE RENAL FAILURE HAD A POOR FUNCTIONING LINE. STANDARD CLEANING OF DIALYSIS CATHETERS WAS WITH GREEN CLINELL DEVICE WIPES, 2% CHLORHEXIDINE, 70% ALCOHOL, AND BD CHLORAPREP ON DRESSING CHANGE DAYS. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE LINE WAS NOT THROMBOSED. THERE WAS NO PROBLEM WITH THE CATHETER'S DIMENSION THAT THEY WERE AWARE OF. NOTHING DOCUMENTED IF THE DIMENSION(S) OF THE CATHETER MATCHED WHAT WAS INDICATED ON THE LABEL. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE LINE WAS REPLACED WITH THE SAME PRODUCT ID (IDENTIFIER) AND LOT AND CHEST X-RAY AS INTERVENTIONS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 19805247 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A PATIENT WITH PARATHYROIDECTOMY, PARATHYROID ADENOMA, NEPHROCALCINOSIS, HYPERCALCAEMIC NEPHROPATHY, CKD4 (STAGE 4 CHRONIC KIDNEY DISEASE), AND PERSONALITY DISORDER HAD STARTED HEMODIALYSIS WITH A NO-KNOWN-ISSUE TEMPORARY JUGULAR LINE ON (B)(6) 2022, WITH POOR COMPLIANCE WITH THE DIALYSIS SCHEDULE AND MEDICATIONS. THE PATIENT WOULD FREQUENTLY NOT ATTEND DIALYSIS SESSIONS; THE PATIENT HAD BEEN KNOWN TO MISS TWO WEEKS WORTH OF SESSIONS IN A ROW. THE PATIENT HAD BEEN EDUCATED MULTIPLE TIMES ON THE POTENTIAL CONSEQUENCES OF MISSING DIALYSIS, BUT IT WAS DIFFICULT TO GET THE PATIENT TO ENGAGE. THE PATIENT ENDED UP COMING INTO THEHOSPITAL THROUGH THE EMERGENCY DEPARTMENT IN EXTREMIS AFTER MISSING MANY SESSIONS. THE PATIENT WOULD BE OFFERED MULTIPLE APPOINTMENTS FOR LINE EXCHANGES BUT WOULD NOT SHOW UP. THE PATIENT WOULD FREQUENTLY DISCHARGE HIMSELF FROM THE HOSPITAL AGAINST MEDICAL ADVICE OR ABSCOND FROM THE WARD. THE PATIENT WAS ELECTED NOT TO HAVE AN AV (ATRIAL VENOUS) FISTULA CREATED. SOMETIMES THE PATIENT WOULD CHOOSE TO ENGAGE WITH THE SERVICE, AND SOMETIMES THE PATIENT WOULD NOT. THE PATIENT SPIKED A TEMPERATURE OF 38 °C ON DIALYSIS ON (B)(6) 2024. THE PAT

  Patient problems: Bacterial Infection; Cough; Fever

  MAUDE report 19801105 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A PATIENT WITH POLYCYSTIC KIDNEY DISEASE, AND END-STAGE RENAL FAILURE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024 WITH NON-FUNCTIONING PD (PERITONEAL DIALYSIS) TUNNELED LINE, HIGH ARTERIAL PRESSURE (HYPERTENSION), PYREXIA, AND STREPTOCOCCUS IN THE BLOOD. THE NURSE ENTRY FROM (B)(6) 2024 WAS THAT THE ENTRY SITE WAS LOOKING VERY INFLAMED AND WEEPING SEROUS FLUID. MEDICAL STAFF THOUGHT THIS WAS AN ALLERGIC REACTION TO THE DRESSINGS. AFTER TRYING A FEW DIFFERENT WAYS OF CLEANING THE LINE SITES DURING PATIENT ADMISSION, IT WAS THOUGHT THAT THE PATIENT WAS ALLERGIC TO CHLORHEXIDINE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. STANDARD CLEANING OF DIALYSIS CATHETERS WAS WITH GREEN CLINELL DEVICE WIPES, 2% CHLORHEXIDINE, 70% ALCOHOL, AND BD CHLORAPREP ON DRESSING CHANGE DAYS. PATCH TESTING CARRIED OUT BY DERMATOLOGY IN (B)(6) 2024 DID NOT SUPPORT A TRUE ALLERGY, BUT THE PATIENT HAD BEEN ADVISED TO AVOID CHLORHEXIDINE-CONTAINING PRODUCTS IN THE FUTURE. THE LINE WAS REPLACED WITH A DIFFERENT PRODUCT ID (IDENTIFIER) AND LOT ON (B)(6) 2024. THE LAST DAY OF HOSPITAL ADMISSION WAS (B)(6) 2024.

  Patient problems: Bacterial Infection; Fever; High Blood Pressure/ Hypertension; Local Reaction

  MAUDE report 19774461 ↗
• MalfunctionJun 19, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, WHILE CATHETER WAS INSIDE PATIENT IN FOLLOW UP AFTER INSERTION, THERE WAS OBSTRUCTION IN FLOW IN VENOUS SIDE. THE DOCTOR REMOVED THE CATHETER AND SHOWED A VIDEO OF FLUSHING CATHETER AFTER REMOVING IT FROM THE PATIENT, WHILE PUSHING FLUID OR FLUSHING THE CATHETER, THE DOCTOR FOUND THAT THE CATHETER LUMEN WAS BLOCKED AND THE SILICON EXTENSION EXPANDED LIKE BUBBLE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NOOTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE CATHETER WAS 13 MONTHS OLD. THE CUSTOMER DID NOT TRY TO REVERSE THE LINES. THE OCCLUSION WAS NOT DUE TO THROMBOSIS. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE INSERTION SITE WAS TREATED WITH BETADINE PRIOR TO PRODUCT PLACEMENT. THE PRODUCT WAS REPLACED WITH THE SAME PRODUCT ID (IDENTIFIER), AND THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS. A 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 19571030 ↗
• MalfunctionApr 24, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE OF THE CATHETER, CONTRAST WAS INJECTED TO PERFORM CT (COMPUTED TOMOGRAPHY) ANGIOGRAPHY. THE CATHETER RUPTURED ONE OF THE PATHWAYS DURING CONTRAST ADMINISTRATION, REQUIRING ITS REMOVAL FOR SUBSEQUENT IMPLANTATION OF A NEW ONE. THERE WAS NO LEAK. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19173632 ↗
• MalfunctionJan 23, 2024Insufficient Flow or Under Infusion; Migration; Insufficient Flow or Under Infusion; Migration

  ACCORDING TO THE REPORTER, THE TUNNELED LINE (WHICH MEANT CENTRAL VENOUS CATHETER) WAS DISLODGED FOLLOWING THE COMMENCEMENT OF HEMODIALYSIS (HD) AT THE PERIPHERAL UNIT OF ANOTHER FACILITY WHEN THE PATIENT TURNED ON THE SIDE. THE FLOW STOPPED AND WAS UNABLE TO RINSEBACK. IT WAS STATED THAT THE NURSES WERE UNABLE TO RETURN THE BLOOD IN THE CIRCUIT TO THE PATIENT, AND THIS MEANT THAT THE FLOW FROM THE LINE CEASED, AND THE NURSES WERE UNABLE TO GET ANY FURTHER FLOW. UPON PRESENTING TO THE FACILITY, THE ON-CALL REGISTRAR WAS CONTACTED. AS A REMEDIAL ACTION, THE PATIENT WAS TRANSFERRED TO WARD 108 OF THE REPORTING FACILITY, WHERE THE LINE HAD BEEN REMOVED AND A TEMPORARY LINE WAS INSERTED. THE PATIENT ALLOWED THE REMOVAL OF THE TUNNELED LINE BUT WOULD NOT ACCEPT A REPLACEMENT LINE AND WAS DISCHARGED AGAINST MEDICAL ADVICE. THE BLOOD WAS SAFE AT THIS TIME, THE POTASSIUM WAS 4.4 MMOL/L (MILLIMOLES PER LITER), AND THE UREA WAS 19.5 MMOL/L. IT WAS STATED THAT PRIOR TO USE, THE NURSING STAFF HAD NOTICED REDNESS AROUND THE ENTRY SITE ON (B)(6),2023, AND THE PATIENT HAD REFUSED TO ATTEND THE DIALYSIS ON (B)(6), 2023, BECAUSE THE PATIENT'S EXIT SITE WAS RED AND CRUSTY. ON (B)(6) 2023, A SWAB WAS

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection

  MAUDE report 18564050 ↗
• MalfunctionJan 4, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE 28 CENTIMETER CATHETER WAS INSERTED AND HAD POOR FUNCTION. IT HAD TO BE REMOVED THE NEXT DAY. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18446394 ↗
• InjuryNov 22, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, ON ARRIVAL AT THE DIALYSIS UNIT AFTER IMPLANTATION OF THE RIGHT INTERNAL JUGULAR (IJ) CHRONIC CATHETER, BLEEDING WAS NOTED TO BE OOZING FROM UNDERNEATH THE DRESSING. ONCE THE DIALYSIS COMMENCED, THE DRESSING WAS ATTENDED TO IMMEDIATELY. THE EXIT SITE WAS CLEANED WITH NORMAL SALINE TO REMOVE BLOOD AND BETADINE. THE EXIT SITE WAS DRESSED WITH SURGICEL, PRIMAPORE, AND (INTRAVENOUS) IV TEGADERM. AFTER COMPLETION OF THE DRESSING, IT WAS NOTED THAT DRIPS OF BLOOD WERE POOLING UNDER THE CATHETER CONNECTION. ON FURTHER INSPECTION, A SMALL "CUT" OR "HOLE" AND THE LOCATION OF THE LEAK WERE NOTED IN THE MIDDLE OF THE VENOUS LINE (LUMEN) EXTENSION TUBE JUST UNDER THE CLAMP. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE WITH A NORMAL RESULT. BESIDES THE SMALL CUT, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE CATHETER WAS NOT REPAIRED, AND THE CATHETER HAD ONLY BEEN IN FOR A FEW HOURS. TEGO WAS NOT UTILIZED. STANDARD BLOODLINES AND SYRINGES WERE UTILIZED WITH THE DEVICE. THE CLEANING AGENT USED ON THE DEVICE WAS ALCOHOLIC CHLORHEXIDINE. THE INSERTION SITE WAS TREAT

  Patient problems: Insufficient Information

  MAUDE report 18196842 ↗
• InjuryJun 30, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING TREATMENT, IT WAS FOUND THAT LESS THAN 1 ML OF BLOOD WAS LEAKING FROM A SMALL GAP WHERE THE EXTENSION TUBE WAS ATTACHED TO THE HUB. THE CUSTOMER WAS UNCERTAIN IF IT WAS THE VENOUS SIDE THAT HAD AN ISSUE. THE CUSTOMER STATED THAT THE LEAK APPEARED DUE TO PARTIAL DISCONNECTION OF THE EXTENSION TUBE. THE CATHETER WAS NOT REPAIRED. ALCOHOLIC CHLORHEXIDINE WAS THE CLEANING AGENT USED ON THE DEVICE AND USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. STANDARD BLOODLINES, SYRINGES AND BD Q-SYTE WERE UTILIZED ON THE DEVICE. FLUSHING WAS DONE PRIOR TO USE AND HAD A NORMAL OUTCOME. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO DAMAGES NOTED ON THE PRODUCT WHERE THE LEAK WAS OBSERVED (NONE OTHER THAN WHAT WAS REPORTED). THE EXTENSION WAS CLAMPED ABOVE THE HUB AND CLAMPS WERE MOVED TO A NEW LOCATION AFTER EACH TREATMENT. TREATMENT WAS STOPPED. A FEMORAL ACUTE CATHETER WAS INSERTED AT THE FACILITY TO FACILITATE ONGOING DIALYSIS. THE PATIENT WAS THEN TRANSFERRED APPROXIMATELY 300 KILOMETERS TO HAVE THE AFFECTED CHRONIC CATHETER REMOVED/RE-WIRED AND ANOTHER ONE REPLACE

  Patient problems: Insufficient Information

  MAUDE report 17243838 ↗
• MalfunctionMay 15, 2023Leak/Splash; Product Quality Problem; Leak/Splash; Product Quality Problem

  ACCORDING TO THE REPORTER, BEFORE SURGERY, THE PEEL-AWAY SHEATH HAD A RUPTURE. THERE WAS NO LEAK. NO CLEANING USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16935305 ↗
• InjuryJan 20, 2023Product Quality Problem; Device Damaged Prior to Use; Product Quality Problem; Device Damaged Prior to Use

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE PEEL AWAY SHEATH END WAS ROUGH INSTEAD OF SMOOTH WHICH CAUSED EXCESS BLEEDING. THERE WAS NO LUER ADAPTER ISSUE. ADDITIONAL STITCHES WERE REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16214047 ↗
• MalfunctionDec 28, 2022Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, IN BETWEEN DIALYSIS SESSION, IT WAS FOUND THAT THE VENOUS EXTENSION TUBE NEAR THE LUER ADAPTER WAS BROKEN; IT HAD A HOLE AND BLOOD LEAK WAS FOUND IN IT. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, NO OTHER PRODUCTS WERE UTILIZED, CLAMPS WERE MOVED TO A NEW LOCATION AFTER EACH TREATMENT, AND FLUSHING WAS PERFORMED WITH NORMAL RESULT. THE DEVICE WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE AND TREATMENT WAS COMPLETED. THERE WAS A SMALL AMOUNT/UNSPECIFIED AMOUNT OF BLOOD LOSS, BLOOD TRANSFUSION WAS NOT REQUIRED AND THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060023 ↗
• DeathAug 25, 2022Insufficient Flow or Under Infusion; Defective Component; Insufficient Flow or Under Infusion; Defective Component

  ACCORDING TO THE REPORTER, AT THE START OF HEMODIALYSIS SESSION, THERE WAS LOW FLOW, ARTERIAL AND VENOUS PATHWAYS DID NOT FUNCTION PROPERLY AND THERE WAS VENOUS THROMBOSIS. THE LINE WAS DIFFICULT TO WASH WITH THE SYRINGE. THE REPORTED CATHETER WAS ONE OF LOT NUMBERS THAT WERE BEING RECALLED (UNDER FA1244). THE PLACE OF INSERTION WAS AT THE VFD (RIGHT FEMORAL VEIN). LAST KT/V (DATE) (K- DIALYZER CLEARANCE OF UREA, T- DIALYSIS TIME, V- VOLUME OF DISTRIBUTION OF UREA) WAS 1.01 ON (B)(6) 2022. BLOOD PUMP FLOW WAS 150 ML/MIN. EFFECTIVE FLOW WAS 100 ML/MIN. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS/DAMAGE FOUND IN THE PRODUCT. TEGO WAS NOT UTILIZED. THE CATHETER WAS NOT REPAIRED, NO LUER ADAPTER ISSUE AND THERE WAS NO LEAK. QUANTITY OF SHORT STAY CATHETERS THAT THE PATIENT HAD USED WAS 6, 2 AT THE VJID (RIGHT INTERNAL JUGULAR VEIN), 2 AT THE VJIE (LEFT INTERNAL JUGULAR VEIN) AND 2 AT THE VFE (LEFT FEMORAL VEIN). QUANTITY OF LONG STAY CATHETERS THAT THE PATIENT HAD USED WAS 2, 1 AT THE VFD (RIGHT FEMORAL VEIN), AND 1 AT THE VFD (RIGHT FEMORAL VEIN). THE CATHETER WAS CHANGED ON 7/9 AND THE PLACE OF INSERTION WAS

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15294178 ↗
• MalfunctionAug 23, 2022Insufficient Flow or Under Infusion; Defective Component; Insufficient Flow or Under Infusion; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER HAD A LOW FLOW ISSUE. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. IT WAS ALSO STATED THAT THE DEVICE WAS A RECALLED PRODUCT (RECALL FA1244). 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 15275340 ↗
• InjuryAug 17, 2022Insufficient Flow or Under Infusion; Defective Component; Insufficient Flow or Under Infusion; Defective Component

  ACCORDING TO THE REPORTER, THE CATHETER WAS FIRST INSERTED ON (B)(6) AND THE INSERTION SITE WAS AT THE (VFD) RIGHT FEMORAL VEIN. ON (B)(6), IT WAS SAID THAT THE CATHETER HAD LOW FLOW ISSUES, ARTERIAL/VENOUS PATHWAYS DID NOT FUNCTION PROPERLY AND ALTEPLASE THROMBOLYTIC AGENT WAS NEEDED AS MEDICAL INTERVENTION DUE TO THE EVENT. ALSO, THERE WAS A DEEP VEIN THROMBOSIS OF LEFT LOWER LIMB. ON (B)(6), THE CATHETER WAS CHANGED. BLOOD PUMP FLOW WAS 280 ML/MIN AND EFFECTIVE FLOW WAS 250 ML/MIN. LAST KT/V (K- DIALYZER CLEARANCE OF UREA, T- DIALYSIS TIME, V- VOLUME OF DISTRIBUTION OF UREA) WAS 1.74 ON (B)(6) 2022. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. QUANTITY OF SHORT STAY CATHETERS THAT THE PATIENT HAD USED WERE SEVEN WITH PLACEMENT SITES 1 VSCD (RIGHT SUBCLAVIAN VEIN), 3 VJID (RIGHT INTERNAL JUGULAR VEIN), 1 VFD (RIGHT FEMORAL VEIN) AND 2 VFE (LEFT FEMORAL VEIN) WHILE THE QUANTITY OF LONG STAY CATHETERS THAT THE PATIENT HAD USED WERE FOUR WITH PLACEMENT SITES 1VJID (RIGHT INTERNAL JUGULAR VEIN), 1VFD (RIGHT FEMORAL VEIN) AND 2 VFE (LEFT FEMORAL VEIN). ADDITIONALLY, THE CATHETER WAS A RECALLED PRODUCT UNDER RECALL FA1244. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15241419 ↗
• MalfunctionAug 17, 2022Insufficient Flow or Under Infusion; Defective Component; Insufficient Flow or Under Infusion; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER HAD A LOW FLOW ISSUE. IT WAS SAID THAT THERE WAS A PRESENCE OF CLOTS WHEN ASPIRATING BOTH ROUTES/PATHWAYS. ARTERIAL PATHWAY DID NOT FUNCTION PROPERLY. IT WAS SAID THAT ALTEPLASE 1 TIME WAS REQUIRED. BLOOD PUMP FLOW WAS 180 ML/MIN AND EFFECTIVE FLOW WAS 150 ML/MIN. LAST KT/V (K- DIALYZER CLEARANCE OF UREA, T- DIALYSIS TIME, V- VOLUME OF DISTRIBUTION OF UREA) WAS 1.02 ON (B)(6) 2022. IT WAS SAID THAT THE PLACEMENT SITE WAS IN VJID (RIGHT INTERNAL JUGULAR VEIN). THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. IT WAS ALSO STATED THAT THE DEVICE WAS A RECALLED PRODUCT (RECALL FA1244). QUANTITY OF SHORT AND LONG STAY CATHETERS THAT THE PATIENT HAD USED WERE BOTH ONE WITH PLACEMENT SITES VJID (RIGHT INTERNAL JUGULAR VEIN). THERE WERE NO CLINICAL COMPLICATIONS. THERE WAS NO OTHER MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT. 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 15241350 ↗
• InjuryAug 17, 2022Insufficient Flow or Under Infusion; Defective Component; Insufficient Flow or Under Infusion; Defective Component

  ACCORDING TO THE REPORTER, DURING NORMAL USE, THERE WAS LOW FLOW, ARTERIAL AND VENOUS PATHWAYS DID NOT FUNCTION PROPERLY. ON JUNE 22 THE LAST (CLEARANCE OF UREA - DIALYSIS TIME AND VOLUME OF DISTRIBUTION OF UREA) WAS 1.37. THE BLOOD PUMP FLOW WAS 210 (MILLILITER/MINUTES) ML/MIN AND EFFECTIVE FLOW WAS 180 (MILLILITER/MINUTES) ML/MIN. THE CATHETER WAS USED SEVEN TIMES SINCE PLACEMENT OF RECALL CATHETERS. THE NUMBER OF SHORT STAY CATHETER WAS 8 AND THE PLACEMENT SITE WERE 3 VFD (RIGHT FEMORAL VEIN), 1 VJIE (LEFT INTERNAL JUGULAR VEIN) AND 3 VJID (RIGHT INTERNAL JUGULAR VEIN). THE NUMBER OF LONG TERM CATHETER WERE 6 AND THE PLACEMENT SITES WERE 3 VFD (RIGHT FEMORAL VEIN), 1 VJID (RIGHT INTERNAL JUGULAR VEIN) AND 3 VFE (LEFT FEMORAL VEIN). THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE (1ST CATHETER). THE CATHETER WAS ONE OF THE LOT NUMBER BEING RECALLED. THE CATHETER WAS NOT REPAIRED. IT WAS STATED THAT ALTEPLASE THROMBOLYTIC WAS NEEDED AS AN INTERVENTION. IT WAS STATED THAT THE CATHETER WAS ALREADY CHANGED ONCE. THE 1ST CATHETER WAS INSERTED ON (B)(6) 2022 AND THE INSERTION SITE WAS VFE (LEFT FEMORAL VEIN). THE SECOND CATHETER WAS INSERTED ON (B)(6) 2022 AND THE INSERTION SITE WAS VFD (R

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15241115 ↗
• MalfunctionMar 15, 2022Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, POST INSERTION, THERE WAS NO BLOOD FLOW OBSERVED. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. POVIDONE IODINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13771927 ↗
• MalfunctionFeb 8, 2022Break; Material Puncture/Hole; Break; Material Puncture/Hole

  ACCORDING TO THE REPORTER, WHILE CHECKING THE BLOOD FLOW AND FLUSHING WAS PERFORMED DURING PROCEDURE, A LEAK WAS OBSERVED AT THE EXTENSION TUBE (WHICH WAS BETWEEN THE HUB AND THE LUER ADAPTER ON RED PORT) NEAR THE ADAPTER. IT WAS MENTIONED THAT THE LEAK WAS ON THE EXTENSION TUBE. THERE WAS NO VISIBLE CRACK OBSERVED AT THE BIFURCATE AND NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. THE CATHETER WAS NOT REPAIRED AND BETADINE WAS THE CLEANING AGENT USED ON THE DEVICE AND ADAPTERS. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND THE LUMENS WERE FLUSHED PRIOR TO USE WHICH HAD A NORMAL RESULT. NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THE PATIENT WAS TREATED UNDER LOCAL ANESTHESIA (LA) AND THE ANESTHESIA TIME WAS NOT EXTENDED BY GREATER THAN 30 MINUTES. THE DEFECTIVE CATHETER WAS EXPLANTED AND REPLACED WITH A NEW CATHETER ON THE SAME DAY OF THE EVENT TO RESOLVE THE ISSUE AND THE PROCEDURE WAS COMPLETED. THERE WAS BLOOD LOSS OF APPROXIMATELY 10 ML AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13486243 ↗
• MalfunctionOct 7, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE GUIDEWIRE WAS TRAPPED INSIDE THE PUNCTURE NEEDLE AND DEFORMING WAS OBSERVED. THE NEEDLE WAS NEEDED TO BE REMOVED AND REQUIRED A NEW VENIPUNCTURE. THEY REPLACED THE CATHETER AS THE INTERVENTION/TREATMENT REQUIRED AS THE RESULT OF THE EVENT AND TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED, THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE DEVICE, THERE WAS NO DAMAGE TO THE CATHETER ITSELF, AND THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. IT WAS ALSO STATED THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT, THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION, AND 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 12589651 ↗

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.