MAHURKAR Elite 8888221220Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521125735), received between Dec 2, 2019 and Mar 8, 2024 — classified as 1 death, 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2024Break; Defective Component; Break; Defective Component

  ACCORDING TO THE REPORTER, A DEFORMATION WAS DETECTED IN THE BLUE SCALPEL LUER REGION. THE SYRINGE WAS CONNECTED, AND DURING DIALYSIS, AIR RETRACTION OCCURRED. A CRACK WAS OBSERVED ON THE LUER ADAPTER. THEY USED ANOTHER PRODUCT TO LOOSEN OR TIGHTEN THE CONNECTION, AND THE SITE WAS THE SYRINGE IN THE BLUE SCALPEL LUER REGION. THE INSERTION SITE WAS NOT HANDLED PRIOR TO PRODUCT PLACEMENT. TEGO WAS NOT USED. ISODINE WAS THE CLEANING AGENT USED IN THIS DEVICE. THERE WAS NO LEAK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18869161 ↗
• MalfunctionFeb 25, 2024Difficult to Remove; Obstruction of Flow; Difficult to Remove; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING USE, THE GUIDEWIRE WAS STUCK AND THEN THE NEEDLE WAS TRANSFERRED. IT WAS STATED THAT THE OCCLUSION WAS AT THE FRONT END OF THE CATHETER. THERE WAS NO LEAK. THE CATHETER WAS NOT REPAIRED. THE GUIDEWIRE USED WAS THE ONE INCLUDED IN THE CATHETER KIT. FLUSHING WAS DONE PRIOR TO INSERTION WITH GOOD RESULT. THE GUIDEWIRE AND CATHETER WERE REMOVED FROM PATIENT SIMULTANEOUSLY DUE TO THE ALLEGED DEFECT AND THE GUIDEWIRE WAS STILL INTACT WHEN IT WAS REMOVED. AS A REMEDIAL ACTION, THE PRODUCT WAS REPLACED AT THE SAME DAY OF THE EVENT. AFTER REMEDIAL ACTION, THE PATIENT WAS TRANSFERRED TO DIALYSIS CENTER WHERE THE SURGERY TAKE PLACE. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED. THERE WAS NO 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 18775072 ↗
• MalfunctionAug 21, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, A FEW HOURS LATER, AFTER BEING INSTALLED VIA THE FEMORAL APPROACH, THE CATHETER MALFUNCTIONED BECAUSE OF AN OBSTRUCTION, AND THE OCCLUSION WAS DUE TO THROMBOSIS. HEPARIN WAS THE ANTICOAGULANT USED. THE CUSTOMER TRIED TO REVERSE THE LINES. THE CATHETER WAS NOT REPAIRED, AND THERE WAS NO LEAK. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, AND NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. THE INSERTION SITE WAS TREATED PRIOR TO THE PRODUCT PLACEMENT. FLUSHING WAS PERFORMED WITH A NORMAL RESULT. THERE WAS NO BLOOD LOSS AS A RESULT OF THE EVENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE CATHETER WAS REPLACED, AND TREATMENT WAS COMPLETED AFTER RESOLVING THE ISSUE. THE EVENT DID NOT LEAD TO PATIENT HOSPITALIZATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17592603 ↗
• MalfunctionMar 30, 2023Unraveled Material; Material Deformation; Unraveled Material; Material Deformation

  ACCORDING TO THE REPORTER, AFTER OPENING THE CATHETER, THE PHYSICIAN IDENTIFIED THAT THE GUIDE WIRE AND THE INTRODUCER BECAME BENT ( TORTUOSITY) WITH NO POSSIBILITY OF USE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16649027 ↗
• MalfunctionFeb 22, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE CATHETER WAS STICKING IN THE PATIENT'S VEIN, CAUSING LOW FLOW AND HAVING TO CHANGE THE CATHETER TO ANOTHER MANUFACTURER TO COMPLETE THE HEMODIALYSIS. WHEN THE CATHETER WAS REMOVED FROM THE PATIENT IT CAME OUT LIKE A STYLET FROM THE PATIENT'S VEIN AS INFORMED BY THE OPERATIONAL MANAGER OVER THE PHONE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16422363 ↗
• MalfunctionFeb 20, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THERE WAS CATHETER OBSTRUCTION ISSUE. SOMETIMES ON THE FIRST HEMODIALYSIS IT NO LONGER WORKED. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. SALINE 0.9% 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 THE PRODUCT PLACEMENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO PATIENT HOSPITALIZATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404614 ↗
• MalfunctionFeb 10, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE CATHETER HAD A LOW FLOW ISSUE AND ONLY ONE ROUTE WAS WORKING. IT NEEDED CONSTANT EXCHANGE OF CATHETER AFTER IMPLANTATION AND SUBJECTING THE PATIENT TO A NEW PROCEDURE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE, AND THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. FLUSHING WAS PERFORMED WITH NO PROBLEM RESULT AND THE LINE WAS HARD TO FLUSH WITH THE SYRINGE. IT WAS ALSO STATED THAT WHEN THE PHYSICIAN PUT A COMPETITOR'S CATHETER IN THE SAME PATIENT, THE CATHETER FLOWED NORMALLY AND THEY WERE NOT CRITICAL PATIENTS OR WHO HAVE ALREADY OTHER ACCESS. THE PATIENTS WHO HAD NEVER AN ACCESS BEFORE, WERE NOT OBESE AND DID NOT HAVE A PATHOLOGY THAT MAY COMPROMISE THE FLOW. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE, PHYSIOLOGICAL SERUM 0.9% WAS USED AS THE CLEANING AGENT ON THE DEVICE, AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. IT WAS ALSO MENTIONED THAT EITHER INFLUX OR REFLUX; IT ALWAYS PRESENTS LOW FLOW. THE BLOOD OF THE PATIENT WAS SAFELY RETURNED. THERE WERE N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16350596 ↗
• MalfunctionFeb 3, 2023Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, DURING CATHETER IMPLANTATION, THE CATHETER HAD A LOW CATHETER GUIDE. AT FIRST, THERE WAS NO DEFECT FOUND LIKE FRAYED, COILED OR UNRAVELLED BUT AFTER WRAPPING AROUND THE IMPLANT, IT WAS NOTED. THE DEVICE WAS NOT REPAIRED, TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. AS RECOMMENDED FOR ASEPSIS, CHLORHEXIDINE DEGERMAN AND ALCOHOL WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS NOT PERFORMED PRIOR TO INSERTION AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT. THERE WAS NO OCCLUSION AND NO CATHETER DIMENSION ISSUE. IT WAS STATED THAT IT WAS NECESSARY TO REMOVE THE GUIDE WIRE AND CATHETER SIMULTANEOUSLY IN ONE ACTION DUE ALLEGED DEFECT. THE GUIDE WIRE WAS REMOVED MANUALLY AND NO TOOLS WERE USED. THE GUIDE WIRE WAS STILL INTACT BUT IT WAS FOLDED AND ROLLED. THERE WAS NO EXCESSIVE FORCE USED ON INSERTION AND WITHDRAWAL OF THE GUIDE WIRE. IT WAS STATED THAT IT WAS NECESSARY TO SUBMIT THE PATIENT TO 3 EXCHANGE OF CATHETERS (3 KITS WERE USED) TO RESOLVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16294737 ↗
• MalfunctionFeb 2, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE CATHETER HAD A LOW FLOW ISSUE AND ONLY ONE ROUTE WAS WORKING. IT NEEDS FOR CONSTANT EXCHANGE OF CATHETER AFTER IMPLANTATION AND SUBJECTING THE PATIENT TO A NEW PROCEDURE. IT WAS ALSO STATED THAT WHEN THE PHYSICIAN PUTS A COMPETITOR'S CATHETER IN THE SAME PATIENT, THE CATHETER FLOWS NORMALLY AND THEY WERE NOT CRITICAL PATIENTS OR WHO HAVE ALREADY OTHER ACCESS. THE PATIENTS WHO HAD NEVER AN ACCESS BEFORE, WERE NOT OBESE AND DID NOT HAVE A PATHOLOGY THAT MAY COMPROMISE THE FLOW. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16283515 ↗
• MalfunctionDec 27, 2022Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove

  ACCORDING TO THE REPORTER, THE DOCTOR INFORMED THAT DURING AN ULTRASOUND GUIDED PUNCTURE OF THE FEMORAL VEIN AT THE HOSPITAL RIOMAR, THE GUIDE WIRE OF THIS REPORTED CATHETER BENT INSIDE THE PATIENT'S VEIN, MAKING A NINETY-DEGREE ANGLE, MAKING IT DIFFICULT TO REMOVE THE CATHETER AND IT FORMED A HEMATOMA AT THE PUNCTURE SITE. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. TEGO WAS NOT UTILIZED. THE CATHETER WAS NOT REPAIRED. IT WAS STATED THAT THIS WAS POSING A RISK TO PATIENT SAFETY. 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: Hematoma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051422 ↗
• MalfunctionDec 22, 2022Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove

  ACCORDING TO THE REPORTER, THE DOCTOR INFORMED THAT DURING DEEP VENIPUNCTURE, THE GUIDE WIRE BENT AND GOT STUCK IN THE PATIENT. THE DOCTOR ALSO INFORMED THAT THIS WAS NOT THE FIRST TIME THAT THIS FACT HAS OCCURRED, LEADING TO RISK FOR THE PATIENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16035936 ↗
• DeathDec 15, 2022Product Quality Problem; Insufficient Flow or Under Infusion; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Insufficient Flow or Under Infusion; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 12 HOURS AFTER CATHETER IMPLANTATION, THE PATIENT IN THE INTENSIVE CARE UNIT OF THE HOSPITAL HAD A COMPLICATION. THE PATIENT WAS DIAGNOSED WITH HEMOTHORAX AND PNEUMOTHORAX. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THE EVENT EXTENDED PATIENT HOSPITALIZATION. THE PATIENT DIED.

  Patient problems: Hemothorax; Pneumothorax

  MAUDE report 15992694 ↗
• InjuryNov 11, 2022Material Fragmentation; Unraveled Material; Material Fragmentation; Unraveled Material

  ACCORDING TO THE REPORTER, DURING THE PASSAGE/INSERTION, THE GUIDE WIRE WAS BENT, CRUMPLED, TWISTED AND COILED, MAKING DIFFICULTY IN PASSING THE CATHETER AND CAUSING THE NEED FOR ANOTHER CATHETER TO PERFORM THE PUNCTURE. THE GUIDE WIRE WAS NOT INTACT. THE PIECES WERE RETRIEVED FROM THE PATIENT. THE GUIDE WIRE WAS NOT STUCK. NO EXCESSIVE FORCE APPLIED ON THE PRODUCT. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT. THE DIMENSION OF THE CATHETER AND THE GUIDE WIRE MATCHED WHAT WAS INDICATED ON THE LABEL. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT OCCLUDED. TEGO WAS NOT UTILIZED. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE PRODUCT WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT ON THE SAME DAY AND THE PROCEDURE WAS COMPLETED. NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THERE WAS NO REPORT OF BLOOD LEAK/BLOOD LOSS.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15783589 ↗
• MalfunctionNov 1, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE GUIDEWIRE COULD NOT BE REMOVED FROM THE INSIDE OF THE PUNCTURE NEEDLE (IT COULD NOT BE ADVANCED ANYMORE, EITHER), THEREFORE, THE NEEDLE BECAME UNABLE TO BE REMOVED FROM THE BLOOD VESSEL. IT WAS SAID THAT THE GUIDEWIRE WAS REMOVED TOGETHER WITH THE NEEDLE WITH FORCE. NOTHING UNUSUAL WAS OBSERVED PRIOR TO PROCEDURE. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS DISINFECTED (UNKNOWN DISINFECTANT SOLUTION) BEFORE PRODUCT PLACEMENT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. IT WAS PRESUMED THAT THERE WAS NO ABNORMALITY NOTED IN THE GUIDEWIRE BEFORE USE, BUT IT WAS AT THE VISUAL LEVEL. NO OCCLUSION WAS NOTED ON THE DEVICE. THE GUIDEWIRE AND NEEDLE WERE PART OF THE KIT BEING USED. FLUSHING WAS NOT DONE PRIOR TO USE. THE DIMENSION(S) OF THE GUIDEWIRE AND THE NEEDLE WERE MATCHED WITH WHAT WAS INDICATED ON THE LABEL. THERE WAS A RESISTANCE NOTED DURING INSERTION/REMOVAL OF THE GUIDEWIRE FROM THE NEEDLE BUT NO EXCESSIVE FORCE WAS USED. SINCE THE GUIDEWIRE WAS INSIDE THE NEEDLE, IT COULD NOT BE CHECKED IF THE GUIDEWIRE WAS STILL INTACT WHEN THE GUIDEWIRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12729596 ↗
• MalfunctionMay 4, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE GUIDE WIRE WAS STUCK IN THE NEEDLE AND COULD NOT BE PULLED OUT. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LUER ADAPTER ISSUE. EXCESSIVE FORCE WAS REQUIRED TO REMOVE THE GUIDE WIRE. WHEN THE GUIDE WIRE WAS REMOVED, IT WAS DAMAGED/BENT NEAR THE J-SHAPE AT THE TIP. THE GUIDE WIRE WAS STILL INTACT. THE ISSUE WITH THE GUIDE WIRE WAS NOT NOTICED IN THE PACKAGING. THE GUIDE WIRE AND NEEDLE USED WERE THE ONES INCLUDED IN THE KIT. THE DIMENSION OF THE NEEDLE AND THE GUIDE WIRE MATCHED WHAT WAS INDICATED ON THE LABEL. THERE WAS NO DAMAGE TO THE DEVICE'S BOX OR PACKAGING. THE PRODUCT RECEIVED BY THE CUSTOMER WAS WELL SEALED. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WAS NO BLOOD LOSS. NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THEY OPENED A NEW PRODUCT TO RESOLVE THE ISSUE ON THE SAME DAY OF EVENT. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11768909 ↗
• MalfunctionJul 24, 2020Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, THE CATHETER WAS INSERTED FROM LEFT INTERNAL JUGULAR VEIN AND DIALYSIS WAS PERFORMED, BUT IT WAS STATED THAT RECIRCULATION WAS OCCURRED AND THE CATHETER WAS REMOVED. INSUFFICIENT FLOW WAS OBSERVED AND THE CATHETER WAS FOUND TO BENT. THE CATHETER WAS NOT REPLACE AND THE GRAPH WAS ABLE TO USED, SO A PUNCTURE WAS MADE FROM THE GRAPH FOR TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10324176 ↗
• MalfunctionMay 7, 2020Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THEY SAID THAT THE GUIDEWIRE DID NOT PROGRESS THROUGH THE LUMEN OF THE CATHETER EXITING THROUGH THE LATERAL GROOVE OF THE VENOUS LUMEN. THE PROCEDURE WAS FOR A CATHETER REPLACEMENT USING THE GUIDEWIRE, FOR THE CATHETER THAT WAS ALREADY IMPLANTED IN THE PATIENT, THEY SAID THAT IT WAS NECESSARY TO REMOVE THE CATHETER COMPLETELY TO CHECK WHY THE GUIDEWIRE DID NOT PROGRESS. THE IMPLANTED CATHETER TO THE PATIENT WAS REMOVED AND A NEW PUNCTURE WAS NEEDED IN ANOTHER LOCATION. NORMAL FLUSHING WAS DONE BEFORE USE AND THERE WAS NOTHING UNUSUAL OBSERVED TO THE PRODUCT DURING VISUAL INSPECTION, AFTER REMOVING THE CATHETER, THE GUIDEWIRE THAT WAS USED IN THE KIT WAS EMERGED WITHOUT DIFFICULTY AND WHEN IT WAS REMOVED IT WAS STILL INTACT BUT LOCATED OUTSIDE THE CATHETER ACCORDING TO THE IMAGES SENT. IT WAS SAID THAT X-RAY WAS NOT PERFORMED AFTER THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS SEEN BY THE PATIENT DUE TO THE EVENT. THIS EVENT DID NOT LEAD TO EXTEND PATIENT'S HOSPITALIZATION TIME, BUT THERE WAS AN INCREASE IN SURGICAL TIME. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WERE NOT REQUIRED, THE DEVICE WAS REPLACED BY ANOTHER M

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10031542 ↗
• MalfunctionDec 2, 2019Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE CLAMP WAS OPENED WHEN THE CATHETER WAS INSTALLED ON THE VENOUS SIDE OF THE CATHETER. CATHETER WAS NOT REPAIRED, TEGO WAS NOT UTILIZED, THERE WAS NO LEAK, NO LUER ADAPTER ISSUE, NO PATIENT SYMPTOMS OR COMPLICATIONS WITH EVENT, MEDICAL OR SURGICAL INTERVENTION WAS NOT NEEDED, DID NOT LEAD TO PATIENT HOSPITALIZATION, NOTHING UNUSUAL OBSERVED PRIOR TO USE, BLOOD TRANSFUSION DONE, CLORHEXIDINA WAS USED ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. CATHETER WAS CHANGED TO COMPLETE TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9397789 ↗

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.