MAHURKAR Elite 8888233216Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10884521127661), received between Oct 13, 2020 and Nov 15, 2024 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (32 reports).

2 other recalls cover devices cleared under the same FDA submission (K120674); 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.

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.

• MalfunctionNov 15, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE IN A VERY STRESSFUL ENVIRONMENT IN THE ICU, THE GUIDEWIRE DID NOT GO THROUGH THE TRIPLE LUMEN. SO IT WAS NOT POSSIBLE TO GET THE CATHETER OVER THE WIRE AS IT DID NOT EXIT AND WAS BLOCKED. THE ANESTHESIOLOGIST THEN CHANGED TO ANOTHER CATHETER WITH THE SAME GUIDEWIRE, AND THE NEW CATHETER WAS PLACED SUCCESSFULLY. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCT WAS UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO BLOOD TRANSFUSION PERFORMED. IT WAS STATED THAT THE ACUTE PATIENT IN THE ICU DIED DUE TO OTHER CAUSES AND WAS BOTH RESPIRATORY AND CARDIAC VERY ILL.

  Patient problems: Insufficient Information

  MAUDE report 20694007 ↗
• MalfunctionNov 14, 2024Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE WIRE WAS UNLABELED. THERE HAD NOT BEEN MANY TIMES THE WIRE HAD BEEN PUSHED BACK; THE SENSATION OF PUSHING IT SEVERAL TIMES HAD NO LONGER BEEN FELT, SO THE METAL NEEDLE HAD BEEN REMOVED. TEGO WAS NOT USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685280 ↗
• MalfunctionOct 9, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, WHILE THE USAGE METHODS REMAINED UNCHANGED, AN INCIDENT OCCURRED WHERE BLOOD DID NOT FLOW DURING ITS USE. USAGE WAS DISCONTINUED DUE TO SUSPICION OF CATHETER LUMEN OBSTRUCTION. THERE WAS NO LEAK. THERE WERE NO PROBLEM WITH THE LUER ADAPTER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408126 ↗
• MalfunctionSep 12, 2024Filling Problem; Filling Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CATHETER WAS TRANSFERRED TO THE FIELD. THE TECHNICIAN TRIED TO FLUSH THE CENTRAL THIRD LUMEN, BUT THE SOLUTION WOULD NOT EXIT THE TIP. THE PATIENT WAS NOT AFFECTED, AND THE PRODUCT NEVER TOUCHED THE PATIENT BUT WAS TRANSFERRED TO THE STERILE FIELD. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO PROBLEM WITH THE LUER ADAPTER. SALINE FLUSH WAS THE CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS HANDLED PRIOR TO PRODUCT PLACEMENT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. THE REMEDIAL ACTION PERFORMED WAS USED AND REPLACED WITH A WITH A DIFFERENT CATHETER, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. NO MEDICAL INTERVENTION OR TREATMENT IS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT OUTCOME.

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

  MAUDE report 20200371 ↗
• MalfunctionAug 28, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CATHETER WAS TRANSFERRED TO THE FIELD. THE TECH TRIED TO FLUSH THE CENTRAL THIRD LUMEN, BUT THE SOLUTION WOULD NOT EXIT THE TIP. THIS HAPPENED TO TWO CATHETERS. THE PATIENT WAS NOT AFFECTED, AND THE PRODUCT NEVER TOUCHED THE PATIENT BUT WAS TRANSFERRED TO THE STERILE FIELD. ASIDE FROM THE CATHETER WOULD NOT FLUSH, NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. SALINE FLUSH WAS THE CLEANING AGENT USED ON THE DEVICE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THE PRODUCT WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT REQUIRED. NO MEDICAL INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20088091 ↗
• MalfunctionJul 26, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING PRIMING PRIOR TO USE, WHEN ATTEMPTING TO PASS SALINE SOLUTION THROUGH THE 3RD LUMEN WITH A SYRINGE, THE LIQUID DID NOT ENTER. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO PROBLEM WITH THE CONNECTOR. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE EXCEPT FOR THE FLASH. THERE WAS NO DAMAGE TO THE EXTERNAL PACKAGING AND THE BOX THAT THE DEVICE CAME IN. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE PRODUCT WAS REPLACED WITH ANOTHER CATHETER, WHICH WAS THE INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE SHEATH/CATHETER THAT CAME WITH THE KIT WAS THE ONE USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840182 ↗
• MalfunctionJul 24, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE TRIPLE LUMEN (INJECTION PORT) COULD NOT FLUSH OR WITHDRAW. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818277 ↗
• MalfunctionJul 12, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE (PRIOR TO VESSEL INSERTION), THE LUMEN PENETRATION WAS CONFIRMED WITH SYRINGE. THE INFUSION LUMEN WAS FOUND TO BE BLOCKED, SO AN EXAMINATION WAS REQUESTED. CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO CONNECTOR PROBLEM. NOTHING UNUSUAL OBSERVE ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER VISIBLE DEFECT/DAMAGE NOTED. THERE WAS NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE USED ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. AS A REMEDIAL ACTION THEY SUPPORTED BY SUBSTITUTE PRODUCT. THE PROCEDURE WAS COMPLETED AFTER RESOLVING THE ISSUE. NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. NO INTERVENTION/MEDICAL TREATMENT REQUIRED AS THE RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19731309 ↗
• MalfunctionJun 28, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING INSERTION OF VASCULAR CATHETER, FOR INITIATION OF CONTINUOUS RENAL REPLACEMENT THERAPY. THE DOCTOR IN-CHARGE PROCEEDED TO PERFORM THE PROCEDURE IN A STERILE ENVIRONMENT. ALL LUMENS WERE FLUSHED WITH NORMAL SALINE 0.9% SOLUTION PRIME THE CATHETER PRIOR TO INSERTION. THE DOCTOR HAD ADVANCED THROUGH THE PROCEDURE AND ATTEMPTED TO INSERT THE GUIDE WIRE THROUGH THE CATHETER AFTER DILATION OF VEIN BUT WAS NOT ABLE TO. REPORTING NURSE WAS INFORMED OF THE INCIDENT AND HAD FLUSHED THE LUMENS OF THE DEFECTIVE DEVICE FOR RECTIFICATION. FROM THE ASSESSMENT, THE ACCESS AND RETURN PORT WAS PATENT UPON FLUSHING BUT THERE WAS RESISTANT IN THE THIRD LUMEN. THE DOCTOR IMMEDIATELY REMOVED THE DEVICE AND CALLED FOR REPLACEMENT OF ANOTHER VASCULAR CATHETER. THERE WAS A SLIGHT DELAY FOR ABOUT 5 MINUTES. DOCTOR PERFORMING THE PROCEDURE HAD APPLIED ACTIVE COMPRESSION OF VESSEL WHILE WAITING FOR THE DEVICE REPLACEMENT AND PREPARATION. THE PATIENT WAS NOT REQUIRED ON GENERAL ANESTHESIA. THE PROCEDURE WAS EVENTUALLY COMPLETED. THE PRODUCT WAS REPLACE WITH THE SAME DEVICE FROM SAME MANUFACTURER. NO DIFFICULTY ENCOUNTERED DURING REMOVAL OF DEVICE FROM PACKAGING. THE CATHETER W

  Patient problems: Insufficient Information

  MAUDE report 19634722 ↗
• MalfunctionJun 14, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, JUGULAR ACCESS WAS TAKEN WITH THE SELDINGER IN PLACE AND DILATION WAS PERFORMED, BUT DURING THE CATHETER INSERTION IN THE SELDINGER (GUIDE WIRE), IT WAS NOT POSSIBLE TO PROCEED WITH THE INSERTION BECAUSE OF OCCLUSION OF THE DISTAL HOLESAT THE GREEN TIP WAS NOTED. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE GUIDEWIRE USED WAS NOT INCLUDED IN THE KIT. THE PROCEDURE HAD BEEN COMPLETED USING A NEW SET OF THE SAME TYPE, SAME LOT ON THE SAMEDAY AS INTERVENTION REQUIRED AS A RESULT OF THE EVENT. THERE WAS UNSPECIFIED AMOUNT OF BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19538059 ↗
• MalfunctionJun 7, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, A CRACK AND LEAK WAS FOUND IN THE CATHETER BRANCH (AROUND THE JUNCTION OF THE EXTENSION TUBE AND THE BRANCH JOINT). THERE WERE NO PROBLEMS WITH THE LUER ADAPTER. REPLACEMENT WAS PERFORMED ON THE SAME DAY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488337 ↗
• MalfunctionJun 5, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, AFTER VENIPUNCTURE AND GUIDE PLACEMENT, THE CATHETER DID NOT SLIDE OVER THE GUIDE WIRE. AT THE TIP LEVEL, THERE WAS AN OCCLUSION OR OBSTRUCTION IN THE LUMEN OF THE DEVICE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE GUIDE WIRE USED THE ONE INCLUDED IN THE KIT. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS NOT PERFORMED PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THEY USED ANOTHER KIT SAME LOT SAME DAY SAME MANUFACTURER AS INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469251 ↗
• MalfunctionApr 22, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, WHEN PREPARING FOR THE SURGERY, AN INTERVIEW WITH THE PHYSICIAN, WHO WAS IN CHARGE OF THE DEPARTMENT OF NEPHROLOGY AND HYPERTENSION, STATED THAT THE PROBLEM IN THIS CASE WAS THAT THE CENTER LUMEN WAS CLOGGED. THEY TRIED TO PASS SALINE THROUGH THE CENTER LUMEN, BUT THEY WERE UNABLE TO GET IT THROUGH. FURTHERMORE, WHEN THEY TRIED TO PASS THE GUIDE WIRE THROUGH, IT DID NOT PASS. THE COMPONENT INVOLVED IN THE PROBLEM WAS JUST THE CATHETER. THE GUIDEWIRE WAS NOT FRAYED, COILED OR UNRAVELED. NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. NO PACKAGING DAMAGE. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE REPORTED DEVICE. NO EXCESSIVE FORCE USED ON THE REPORTED DEVICE. NO CLEANING AGENT USED. THEY NOTICED IT BEFORE USING IT ON A PATIENT, SO THEY DID NOT USE IT ON A PATIENT, THE PRODUCT WAS NEVER IMPLANTED, AND IT WAS RESPONDED WITH AN OTHER PRODUCT OF THE SAME BRAND AS REMEDIAL ACTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154162 ↗
• MalfunctionMar 29, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, IN ORDER TO PREPARATION PRIOR TO INSERTION, SALINE WAS INJECTED INTO EACH LUMEN, BUT IT COULD NOT BE INJECTED INTO THE CENTER LUMEN (WHITE) AT ALL. IT WAS MENTIONED THAT THEY COULD NOT PRESSED THE PLUNGER WITH A SYRINGE FOR BOTH NEGATIVE AND POSITIVE PRESSURE. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO CONNECTOR ISSUE. THEY WERE NOT ABLE TO PERFORM FLUSHING. THERE WERE NO OTHER DAMAGES FOUND ON THE PRODUCT. THE PRODUCT WAS REPLACED WITH A NEW DEVICE OF THE SAME PRODUCT ID AND OUT OF THE SAME BOX AS THE SAME DATE OF THE EVENT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006524 ↗
• MalfunctionMar 28, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, A SALINE WAS INJECTED INTO EACH LUMEN, BUT IT COULD NOT BE INJECTED INTO THE CENTER LUMEN (WHITE) AT ALL. THERE WAS NO REPORTED PATIENT OUTCOME.

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

  MAUDE report 18991243 ↗
• MalfunctionMar 6, 2024Difficult to Remove; Obstruction of Flow; Difficult to Remove; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING INSERTION, THE GUIDEWIRE WAS UNABLE TO PASS. THERE WAS A POSSIBILITY THAT THE LUMEN OF THE INFUSION ROUTE MAY NOT BE EMPTY. AFTER THAT, TRIED TO PULL WITH A SYRINGE, BUT IT COULD NOT BE PULLED. IT WAS STATED THAT THERE WAS A POSSIBILITY OF OCCLUSION ON THE CATHETERS BUT THE DETAILS WERE UNKNOWN. THE GUIDEWIRE WAS NOT FRAYED OR COILED WHEN TRYING TO INSERT AND REMOVE. THERE WAS NO LEAK AND THERE WAS NO PROBLEM WITH THE LUER ADAPTER. THERE WAS NOTHING UNUSUAL OBSERVE ON THE DEVICES PRIOR TO USE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCTS AT THE TIME OF THE EVENT. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS NOT HANDLED PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS NOT REPLACED. AS A REMEDIAL ACTION, IT WAS RESPONDED WITH A NEW CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED. THERE WAS NO MEDICAL INTERVENTION/TREATMENT DONE TO THE PATIENT AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18849543 ↗
• MalfunctionJan 30, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, ALL LUMENS WERE FLUSHED BEFORE THE CATHETER WAS PLACED AND IT WAS NOTED THAT THE THIRD LUMEN WAS NOT PATENT AND WAS NOT OPEN. THE REPORTED PRODUCT DID NOT COME IN CONTACT WITH A PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607987 ↗
• MalfunctionJan 23, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING FLUSHING THE LUMEN BEFORE INSERTING VIA THE GUIDEWIRE, IT WAS OBSERVED THAT THE THIRD LUMEN WAS NOT OPEN AND CANNOT BE FLUSHED (NOT PATENT), SO THE CUSTOMER CANNOT USE THAT CATHETER. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. THERE WAS NO DAMAGE TO THE OUTER PACKAGING AND INNER PACKAGING OF THE REPORTED PRODUCT. THE STERILE BARRIER WAS INTACT. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS THE LUMEN WAS ¿CLOGGED¿. BESIDES THE REPORTED ISSUE THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE CLEANING AGENT USED ON THE DEVICE WAS OCTENIDERM. TEGO WAS NOT UTILIZED. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE REPORTED PRODUCT DID NOT COME IN CONTACT WITH A PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER OF THE SAME LOT. 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 18561116 ↗
• MalfunctionJan 23, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING FLUSHING THE LUMEN BEFORE INSERTING VIA THE GUIDEWIRE, IT WAS OBSERVED THAT THE THIRD LUMEN WAS NOT OPEN AND CANNOT BE FLUSHED (NOT PATENT), SO THE CUSTOMER CANNOT USE THAT CATHETER. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. THERE WAS NO DAMAGE TO THE OUTER PACKAGING AND INNER PACKAGING OF THE REPORTED PRODUCT. THE STERILE BARRIER WAS INTACT. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS THE LUMEN WAS ¿CLOGGED¿. BESIDES THE REPORTED ISSUE THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE CLEANING AGENT USED ON THE DEVICE WAS OCTENIDERM. TEGO WAS NOT UTILIZED. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE REPORTED PRODUCT DID NOT COME IN CONTACT WITH A PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER OF THE SAME LOT. 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 18561097 ↗
• MalfunctionJan 22, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING FLUSHING THE LUMEN BEFORE INSERTING VIA THE GUIDEWIRE, IT WAS OBSERVED THAT THE THIRD LUMEN WAS NOT OPEN AND CANNOT BE FLUSHED (NOT PATENT), SO THE CUSTOMER CANNOT USE THAT CATHETER. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. THERE WAS NO DAMAGE TO THE OUTER PACKAGING AND INNER PACKAGING OF THE REPORTED PRODUCT. THE STERILE BARRIER WAS INTACT. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS THE LUMEN WAS ¿CLOGGED¿. BESIDES THE REPORTED ISSUE THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE CLEANING AGENT USED ON THE DEVICE WAS OCTENIDERM. TEGO WAS NOT UTILIZED. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE REPORTED PRODUCT DID NOT COME IN CONTACT WITH A PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER OF THE SAME LOT. 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 18554465 ↗
• MalfunctionDec 6, 2023Defective Component; Obstruction of Flow; Defective Component; Obstruction of Flow

  ACCORDING TO THE REPORTER, WHILE INSERTING TO THE PATIENT, THE CUSTOMER TRIED TO INTRODUCE THE CATHETER OVER THE GUIDE WIRE THROUGH ALL THREE "LUMINA"/LUMENS, HOWEVER, IT WAS NOT POSSIBLE TO FEED THE WIRE THROUGH THE CATHETER THROUGH ANY OF THE THREE LUMENS. IT WAS STATED THAT THE CATHETERS WERE NOT CONTINUOUS (NO OPEN LUMINA). THE CENTRAL LUMINA BETWEEN GREEN TIP AND CATHETER SHAFT WHERE GUIDEWIRE PLACED INTO CATHETER WAS OCCLUDED. THERE WERE NO MATERIAL INTO LUMINA BUT THE CENTRAL LUMINA FOR PASSING THE GUIDEWIRE WAS NOT CONSISTENT. THE OCCLUSION WAS NOT DUE TO THROMBOSIS. NOTHING UNUSUAL OBSERVED ON THE DEVICE BEFORE ATTEMPTING TO INSERT THE GUIDEWIRE. THERE WAS NO LEAK. THERE WAS NO DIMENSION ISSUE OBSERVED. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS TREATED WITH OCTENIDERM PRIOR TO PRODUCT PLACEMENT. THE CLEANING AGENT USED ON THE DEVICE WAS ALSO OCTENIDERM. THE GUIDEWIRE WAS PROVIDED WITH THE KIT BEING USED. ONLY THE CANNULA AND GUIDEWIRE FROM THE KIT WERE UTILIZED. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS THE LUMINA WAS CLOSED, SO THE NEXT KIT WAS OPENED. IT WAS STATED THAT AS A REMED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278999 ↗
• MalfunctionDec 6, 2023Defective Component; Obstruction of Flow; Defective Component; Obstruction of Flow

  ACCORDING TO THE REPORTER, WHILE INSERTING TO THE PATIENT, THE CUSTOMER TRIED TO INTRODUCE THE CATHETER OVER THE GUIDE WIRE THROUGH ALL THREE "LUMINA"/LUMENS, HOWEVER, IT WAS NOT POSSIBLE TO FEED THE WIRE THROUGH THE CATHETER THROUGH ANY OF THE THREE LUMENS. IT WAS STATED THAT THE CATHETERS WERE NOT CONTINUOUS (NO OPEN LUMINA). THE CENTRAL LUMINA BETWEEN GREEN TIP AND CATHETER SHAFT WHERE GUIDEWIRE PLACED INTO CATHETER WAS OCCLUDED. THERE WERE NO MATERIAL INTO LUMINA BUT THE CENTRAL LUMINA FOR PASSING THE GUIDEWIRE WAS NOT CONSISTENT. THE OCCLUSION WAS NOT DUE TO THROMBOSIS. NOTHING UNUSUAL OBSERVED ON THE DEVICE BEFORE ATTEMPTING TO INSERT THE GUIDEWIRE. THERE WAS NO LEAK. THERE WAS NO DIMENSION ISSUE OBSERVED. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS TREATED WITH OCTENIDERM PRIOR TO PRODUCT PLACEMENT. THE CLEANING AGENT USED ON THE DEVICE WAS ALSO OCTENIDERM. THE GUIDEWIRE WAS PROVIDED WITH THE KIT BEING USED. ONLY THE CANNULA AND GUIDEWIRE FROM THE KIT WERE UTILIZED. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS THE LUMINA WAS CLOSED, SO THE NEXT KIT WAS OPENED. IT WAS STATED THAT AS A REMED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278958 ↗
• MalfunctionDec 6, 2023Defective Component; Obstruction of Flow; Defective Component; Obstruction of Flow

  ACCORDING TO THE REPORTER, WHILE INSERTING TO THE PATIENT, THE CUSTOMER TRIED TO INTRODUCE THE CATHETER OVER THE GUIDE WIRE THROUGH ALL THREE "LUMINA"/LUMENS, HOWEVER, IT WAS NOT POSSIBLE TO FEED THE WIRE THROUGH THE CATHETER THROUGH ANY OF THE THREE LUMENS. IT WAS STATED THAT THE CATHETERS WERE NOT CONTINUOUS (NO OPEN LUMINA). THE CENTRAL LUMINA BETWEEN GREEN TIP AND CATHETER SHAFT WHERE GUIDEWIRE PLACED INTO CATHETER WAS OCCLUDED. THERE WERE NO MATERIAL INTO LUMINA BUT THE CENTRAL LUMINA FOR PASSING THE GUIDEWIRE WAS NOT CONSISTENT. THE OCCLUSION WAS NOT DUE TO THROMBOSIS. NOTHING UNUSUAL OBSERVED ON THE DEVICE BEFORE ATTEMPTING TO INSERT THE GUIDEWIRE. THERE WAS NO LEAK. THERE WAS NO DIMENSION ISSUE OBSERVED. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS TREATED WITH OCTENIDERM PRIOR TO PRODUCT PLACEMENT. THE CLEANING AGENT USED ON THE DEVICE WAS ALSO OCTENIDERM. THE GUIDEWIRE WAS PROVIDED WITH THE KIT BEING USED. ONLY THE CANNULA AND GUIDEWIRE FROM THE KIT WERE UTILIZED. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS THE LUMINA WAS CLOSED, SO THE NEXT KIT WAS OPENED. IT WAS STATED THAT AS A REMED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18275793 ↗
• MalfunctionNov 21, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, WHEN ATTEMPTING TO PLACE A TEMPORARY DIALYSIS CATHETER (16 CM (CENTIMETER)) IN A PATIENT IN THE INTENSIVE CARE UNIT AND WHEN TRYING TO PLACE A GUIDEWIRE THROUGH THE CATHETER TIP, IT WOULD NOT ADVANCE. THEY THEN TRIED TWO OTHER CATHETERS FROM NEW KITS WITHOUT SUCCESS. ALL THREE CATHETERS DID NOT WORK. IT WAS ALSO STATED THAT THERE WERE TWO OTHER 16-CM CATHETERS THAT HAD BLOCKAGE THAT PREVENTED GUIDEWIRE FROM ADVANCING, WHICH WAS EASILY REPLICATED OUTSIDE OF THE PATIENT. THE LINE WAS FLUSHED PRIOR TO USE WITH NS (NORMAL SALINE), AND NO ISSUES WERE ENCOUNTERED. THE INSERTION SITE WAS TREATED WITH CHLORHEXADINE STICKS PRIOR TO PRODUCT PLACEMENT. THE GUIDE WIRE WAS NOT STUCK. NO EXCESSIVE FORCE WAS APPLIED TO THE PRODUCT. THE GUIDE WIRE WAS STILL INTACT. THE GUIDE WIRE WAS NOT FRAYED, COILED, OR UNRAVELED. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. NO CLEANING AGENT WAS USED ON THE DEVICE. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE DIMENSION OF THE CATHETER AND THE GUIDE WIRE MATCHED WHAT WAS INDICATED ON THE LABEL. THERE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187926 ↗
• MalfunctionNov 21, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, WHEN ATTEMPTING TO PLACE A TEMPORARY DIALYSIS CATHETER (16 CM (CENTIMETER)) IN A PATIENT IN THE INTENSIVE CARE UNIT AND WHEN TRYING TO PLACE A GUIDEWIRE THROUGH THE CATHETER TIP, IT WOULD NOT ADVANCE. THEY THEN TRIED TWO OTHER CATHETERS FROM NEW KITS WITHOUT SUCCESS. ALL THREE CATHETERS DID NOT WORK. IT WAS ALSO STATED THAT THERE WERE TWO OTHER 16-CM CATHETERS THAT HAD BLOCKAGE THAT PREVENTED GUIDEWIRE FROM ADVANCING, WHICH WAS EASILY REPLICATED OUTSIDE OF THE PATIENT. THE LINE WAS FLUSHED PRIOR TO USE WITH NS (NORMAL SALINE), AND NO ISSUES WERE ENCOUNTERED. THE INSERTION SITE WAS TREATED WITH CHLORHEXADINE STICKS PRIOR TO PRODUCT PLACEMENT. THE GUIDE WIRE WAS NOT STUCK. NO EXCESSIVE FORCE WAS APPLIED TO THE PRODUCT. THE GUIDE WIRE WAS STILL INTACT. THE GUIDE WIRE WAS NOT FRAYED, COILED, OR UNRAVELED. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. NO CLEANING AGENT WAS USED ON THE DEVICE. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE DIMENSION OF THE CATHETER AND THE GUIDE WIRE MATCHED WHAT WAS INDICATED ON THE LABEL. THERE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187913 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120674. One submission often covers many models, so check the product and lot details in each record.

• Z-2319-2026 · Apr 29, 2026 · Open, Classified
  Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen
• Z-1007-2018 · Oct 14, 2017 · Terminated
  MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.