MAHURKAR 8888101002HPRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521127968), received between Aug 20, 2018 and Apr 24, 2025 — classified as 1 death, 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

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

30 other recalls cover devices cleared under the same FDA submission (K102605, K192302); 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. Oct 17, 2025Class IIOpen, Classified

   A potential issue with the seal integrity of header bag packaging.

   Z-0422-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jun 28, 2023Class IOpen, Classified

   Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

   Z-2368-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING THE HEMODIALYSIS PROCEDURE, THE GUIDEWIRE FROM THE KIT BECAME UNCOILED. IT WAS UNCLEAR WHETHER THE WIRE WAS REMOVED COMPLETELY AND INTACT. A STAT CHEST X-RAY WAS PERFORMED AND SHOWED NO EVIDENCE OF ANY RETAINED WIRE FRAGMENTS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21900048 ↗
• InjuryJan 8, 2024Material Fragmentation; Unraveled Material; Material Fragmentation; Unraveled Material

  ACCORDING TO THE REPORTER, THE CRITICAL CARE WAS PLACING A DIALYSIS CATHETER INTO THE PATIENT, AND A PIECE OF THE GUIDE WIRE BROKE OFF IN THE PATIENT WHEN THE GUIDEWIRE WAS BEING PULLED OUT. THE GUIDEWIRE BROKE AT THE DISTAL END. THE PATIENT HAD TO BE TRANSFERRED FOR CT (CARDIOTHORACIC) SURGERY TO HAVE IT REMOVED. IT WAS STATED THAT ON REMOVAL OF THE GUIDEWIRE (WHEN THE GUIDEWIRE BROKE OFF ONTHE DAY OF THE EVENT), IT WAS IMMEDIATELY RECOGNIZED THAT THE GUIDEWIRE'S BRAIDED END WAS UNRAVELED AT DISTAL TIP WITH 1 OF THREE BRAID FRAGMENTS FORESHORTENED. THE CXR (CHEST X-RAY) CONFIRMED RADIOPAQUE CURVE LINEAR OPACITY IN THE R (RIGHT) NECK WHICH WAS SUGGESTIVE OF RETAINED GUIDEWIRE FRAGMENT. THE PATIENT WAS SENT FOR CT (COMPUTERIZED TOMOGRAPHY) CHEST WITHOUT CONTRAST, WHICH CONFIRMED RETAINED GUIDEWIRE FRAGMENT IN THE R (RIGHT) PARATRACHEAL AREA. IT WAS STATED THAT IT WAS REVIEWED IMMEDIATELY WITH A VASCULAR SURGERY, ¿IR¿ (INTERVENTIONAL RADIOLOGY), AND ¿CTSX¿ (CARDIOTHORACIC SURGERY). PER ¿IR¿ (INTERVENTIONAL RADIOLOGY) REVIEW, THEY DID NOT BELIEVE THE FRAGMENT TO BE CURRENTLY ENDOVASCULAR AND DID NOT FEEL ¿IR (INTERVENTIONAL RADIOLOGY) APPROACH¿ FOR RETRIEVAL WAS POSSIBLE. THIS WAS DIS

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 18468193 ↗
• MalfunctionNov 30, 2020Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  ACCORDING TO THE REPORTER, DURING INSERTION ON RIGHT SUBCLAVIAN OF THE INITIAL HEALTHCARE PROVIDER, THE GUIDE WIRE WAS NOT THREADING. IT WAS MENTIONED THAT THERE WAS NO APPARENT DAMAGE TO THE GUIDE WIRE OR CATHETER (GUIDE WIRE STILL INTACT). THE NEEDLE WAS USED TO ACCESS THE VEIN PER THE STANDARD PROCESS AND BLOOD RETURN WAS SEEN AS EXPECTED. THE GUIDE WIRE DID NOT ADVANCE INTO THE VESSEL, AND THEN WAS UNABLE TO BE WITHDRAWN. THE CATHETER AND GUIDE WIRE WERE WITHDRAWN TOGETHER. THEY STILL DID NOT GET THE NEEDLE LOOSE FROM THE GUIDE WIRE AFTER WITHDRAWING. IT WAS MENTIONED THAT AFTER THE FIRST PASS, THE PATIENT HAD A SMALL HEMATOMA DEVELOPED WHICH DID NOT CONTINUE TO ENLARGE. PRESSURE WAS HELD OVER THE HEMATOMA AND THE HEMATOMA WAS "RESOLVED". A SECOND KIT WAS OBTAINED AND THE SAME SITUATION OCCURRED. VENOUS RETURN WAS OBTAINED ON SECOND AND THIRD PASS, BUT GUIDEWIRE COULD NOT BE ADVANCED. ON CAROTID, LIGHT PULSATILE BLOOD WAS NOTED. THE NEEDLE WAS IMMEDIATELY WITHDRAWN AND PRESSURE WAS HELD FOR 10 MINUTES. AT THIS POINT, PROCEDURE WAS TERMINATED, AND TRAUMA SURGERY WAS CALLED. THEY HAD TO INVOLVE A CONSULTANT (SECOND HEALTHCARE PROVIDER) AND ADDITIONAL ACCESS WAS CREA TED ON THE OT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10919247 ↗
• InjuryOct 27, 2020Break; Break

  ACCORDING TO THE REPORTER, IT WAS STATED THAT THE DOCTOR WAS AT BEDSIDE PLACING A CATHETER INTO LEFT "SUBCLAVIAN". THE DOCTOR HAD DIFFICULTY PLACING LINE, AND REQUESTED SECOND KIT WHICH WAS OPENED AND A SECOND ATTEMPT TO PLACE LINE WAS UNSUCCESSFUL. USING A GUIDEWIRE HE CONTINUED TO ATTEMPT PLACEMENT. HE REMOVED ALL EQUIPMENT AND ASKED FOR "CXR" CHEST XRAY WHICH IT POSSIBLY APPEARS THAT PART OF THE FIRST CATHETER BROKE OFF AND REMAINS IN PATIENT AND THERE WAS NO REPORTED RETRIEVAL, UPON LOOKING AT ALL WIRES USED, ONE WIRE LOOKED ABNORMAL AS THE THREADING FROM WIRE WAS NOT INTACT. IT WAS MENTIONED THAT WHILE REMOVING THE GUIDEWIRE IT WAS OBSERVED THAT THE END OF WIRE WAS COILED. PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR PLACEMENT OF THE CATHETER AND AFTER FURTHER EVALUATION OF POSSIBLE WIRE REMAINS/RETAINED IN PATIENT. THE DEVICE WAS NOT USED AGAIN TO RESOLVE THE ISSUE. IT WAS REPORTED THAT THE DEVICE WAS NOT REPAIRED AND USED. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Foreign Body In Patient; Injury; Unintended Radiation Exposure

  MAUDE report 10740914 ↗
• MalfunctionOct 26, 2020Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING TREATMENT, THERE WAS A HOLE IN THE JUNCTION OF THE CATHETER EXTENSION TUBE AND BIFURCATE (ON THE BACK END OF THE HUB CONNECTION). THE CATHETER WAS NOT REPAIRED AND NO CLEANING AGENT WAS 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 DAMAGE TO THE DEVICE'S BOX AND PACKAGING AND THE PRODUCT WAS STILL SEALED UPON RECEIPT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND FLUSHING WAS NOT DONE. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE PRODUCT WAS REPLACED WITH A NEW CATHETER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10734727 ↗
• MalfunctionMay 28, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE PLACEMENT OF TRIPLE LUMEN QUINTON CATHETER, THE INSERTION SITE WAS PREPPED WITH CHLORHEXIDINE AND DRAPED IN STANDARD STERILE FASHION. AFTER THE ADMINISTRATION OF ADEQUATE LOCAL ANESTHESIA (LIDOCAINE), USING THE HIGH FREQUENCY LINEAR TRANSDUCER, THE VESSEL WAS INTERROGATED AND ENSURED TO BE PATENT. USING DYNAMIC GUIDANCE, THE NEEDLE WAS DIRECTED TOWARD THE VESSEL, RESULTING IN REAL TIME VISUALIZATION OF VASCULAR NEEDLE ENTRY. THE VEIN WAS CANNULATED WITH THE INTRODUCER NEEDLE AS DEMONSTRATED BY THE RETURN OF DARK RED, NON-PULSATILE BLOOD. A GUIDE WIRE WAS ADVANCED THROUGH THE NEEDLE INTO THE VEIN AND THE NEEDLE WITHDRAWN OVER THE WIRE. ULTRASOUND WAS USED AND VERIFIED POSITION OF THE WIRE IN THE VESSEL. A SMALL SKIN INCISION WAS MADE AT THE INSERTION SITE. THE CATHETER INSERTION TRACT WAS DILATED. SUBCUTANEOUS TISSUE WAS TOUGH AND SKIN INCISION EXPANDED TO FACILITATE DILATION. AFTER SERIAL DILATION, THE CENTRAL VENOUS CATHETER WAS PASSED OVER THE WIRE INTO THE VEIN. AS THE GUIDEWIRE WAS BEING WITHDRAWN, THERE WAS NOTED RESISTANCE. THE WIRE OVER THE CATHETER WAS UNABLE TO BE PULLED OUT. BLOOD FLOW WAS NOTED THROUGH OPEN PORT OF CATHETER. IT WAS A

  Patient problems: Death

  MAUDE report 8647355 ↗
• DeathMay 28, 2019Material Frayed; Material Frayed

  ACCORDING TO THE REPORTER, PATIENT WAS ON AN EMERGENT CASE AND CAME IN WITH CHEST PAIN AND NEEDED STENT PLACEMENT. DURING THE PLACEMENT OF TRIPLE LUMEN DIALYSIS CATHETER, THE PATIENT WAS PLACED IN THE SUPINE POSITION IN MILD TRENDELENBERG. UNDER ULTRASOUND GUIDANCE, THE LEFT FEMORAL VEIN WAS IDENTIFIED. THE PATIENT WAS THEN DRAPED AND PREPPED IN THE USUAL STERILE MANNER. AFTER ADEQUATE LOCAL ANESTHESIA WAS OBTAINED, THE VEIN WAS CANNULATED. USING SELDINGER TECHNIQUE, A GUIDE WIRE WAS ADVANCED WITHOUT RESISTANCE. IMAGING OF THE GUIDEWIRE CONFIRM THAT IT WAS OUTSIDE THE VEIN. GUIDEWIRE WAS REMOVED AND WAS FOUND TO BE KINKED AND ALL BECAME UNRAVELED WITH FIXED RESISTANCE AT ONE POINT. AVAILABLE DILATOR WAS APPLIED, AND THE GUIDEWIRE RETRACTED BUT WAS UNSUCCESSFUL. SMALLER DILATOR WAS USED AND WITH RETRACTION, SUCCESSFULLY REMOVED (COMPLETE). PRESSURE WAS APPLIED TO AREA UNTIL HEMOSTASIS. AT THE SECOND ATTEMPT, USING SELDINGER TECHNIQUE, IT WAS ADVANCED WITHOUT RESISTANCE. AFTER THE SUBCUTANEOUS SKIN WAS APPROPRIATELY DILATED, A FR (FRENCH) 20 CM TRIPLE LUMEN DIALYSIS CATHETER WAS PLACED. FLUSHING WAS DONE, A CLEANING AGENT WAS NOT USED ON THE DEVICE, THE INSERTION SITE WAS TREATED WIT

  Patient problems: Death

  MAUDE report 8646769 ↗
• MalfunctionAug 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING USE, THE LUER ADAPTER WAS DETACHED. IT WAS REPORTED THAT THE THIRD PORT ADAPTER BROKE LOOSE FROM TUBING WHEN THE NURSE TRIED TO REMOVE THE IV (INTRAVENOUS) LINE FROM IT. IT WAS ALSO INDICATED THAT THE NURSE WAS HAVING TROUBLE, TRYING TO DISCONNECT THE IV TUBING FROM THE PIGTAIL HUB ON THE DIALYSIS TRIPLE LUMEN PORT. AFTER A COUPLE OF SECONDS OF WIGGLING THE IV TUBING IN ATTEMPTS TO GET FREE, THE PIGTAIL HUB BROKE OFF FROM THE TUBING, AND NEW TRIPLE LUMEN DIALYSIS CATHETER WAS PLACED AFTER REMOVAL. IT WAS REPORTED THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7798694 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102605, K192302. One submission often covers many models, so check the product and lot details in each record.

• Z-0425-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
• Z-0421-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
• Z-0426-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
• Z-0424-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
• Z-0423-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
• Z-2373-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 8888103001HP
• Z-2385-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 8888345603HP
• Z-2391-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP
• Z-2370-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray REF: 8888101004HP
• Z-2384-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603
• Z-2386-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611
• Z-2383-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP
• Z-2387-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit REF: 8888345611HP
• Z-2374-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 8888103002HP
• Z-2376-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104003HP

…and 15 more.