MAHURKAR 8888345603Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521006768), received between Feb 18, 2019 and Nov 10, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 reports).

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

31 other recalls cover devices cleared under the same FDA submission (K020089, 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. 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-2384-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2021Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove

  ACCORDING TO THE REPORTER, WHEN THE GUIDEWIRE WAS PULLED OUT AS PART OF THE CATHETER INSERTION PROCEDURE, THE HEALTHCARE PROFESSIONAL (HCP) STATED THAT THE GUIDEWIRE GOT KINKED IN THE DISTAL END AND STUCK INSIDE THE CATHETER BLUE VENOUS LINE. WHEN APPLIED FORCE TO PULL THE GUIDEWIRE, THE GUIDE WIRE INTEGRITY GOT LOST, WAS NOT GOOD, THE GUIDE WIRE WAS IN BAD SHAPE, STEEL THREADS/SPRING WIRE OF THE GUIDEWIRE WERE UNCOILED, AND ONCE THE STEEL THREADS THAT WERE UNCOILING WERE PULLED OUT WITH FORCE, THE HCP DECIDED TO PULL THE GUIDE WIRE ALONG WITH CATHETER. THE GUIDE WIRE WAS REMOVED WITH GREAT DIFFICULTY. FORTUNATELY, THE GUIDEWIRE CAME OUT IN ONE PIECE AND WAS STILL INTACT. THE CATHETER WAS REPLACED WITH NEW CATHETER ON THE SAME DAY OF THE EVENT, THE NEW CATHETER WAS USED SUCCESSFULLY, AND THE PROCEDURE WAS COMPLETED. IT WAS STATED THAT IT WAS IN PATIENT¿S BODY THAT WHEN INSERTING THE GUIDEWIRE THROUGH THE CATHETER, IT GOT STUCK. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT, AND THE HCP DID NOT CHECK THE GUIDEWIRE BEFORE INSERTING. PRIOR TO USE, NOTHING UNUSUAL OBSERVED ON THE DEVICE AND FLUSHING WAS DONE WITH NOTHING ABNORMAL NOTICED. THE DIMENSION OF THE CATHETER MATCHED WHA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12786844 ↗
• MalfunctionOct 11, 2021Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHILE FLUSHING THE CATHETER, IT WAS NOTED THAT THE ARTERIAL (RED) LUER ADAPTER WAS CRACKED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK AND TEGO WAS NOT UTILIZED. BETADINE AND CHLORHEXIDINE WERE THE CLEANING AGENTS USED ON THE DEVICE. BETADINE WAS THE CLEANING AGENT USED ON THE INSERTION SITE TREATED WITH PRIOR TO PRODUCT PLACEMENT. THERE WAS NO INSTRUMENT USED INSTEAD HAND WAS USED USED TO LOOSEN OR TIGHTEN THE DEVICE. THERE WAS NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NOTHING UNUSUAL OBSERVED ASIDE FROM THE REPORTED ISSUE PRIOR TO FLUSHING. THERE WAS NO DAMAGE NOTED ON THE DEVICE PACKAGING. THE BOX AND THE STERILE BARRIER THAT THE DEVICE CAME IN WAS STILL INTACT. THE CATHETER WAS REMOVED FROM THE SURGICAL TROLLEY/STERILE AREA AND DISCARDED, A NEW CATHETER WITH SIMILAR MODEL NUMBER WAS FLUSHED SUCCESSFULLY AND INSERTED SUCCESSFULLY IN THE PATIENT. THERE WERE NO OTHER PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605268 ↗
• MalfunctionOct 4, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING PROCEDURE, JUST AFTER THE PLACING THE CATHETER AND WHEN THE ULTEM LUER LOCK ADAPTERS WERE OPEN TO CHECK THE BLOOD FLOW, THE DOCTOR OBSERVED BLOOD LEAKAGE FROM THE EXTENSION TUBE NEAR THE BLUE LUER ADAPTER (EXIT SITE). NO DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED (CRACK, CUT, ETC.). NOTHING UNUSUAL WAS OBSERVED PRIOR TO USE. THE CATHETER WAS NOT REPAIRED. BETADINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED WITH BETADINE PRIOR TO PRODUCT PLACEMENT. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS OKAY. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS A BLOOD LOSS OF APPROXIMATELY 10ML BUT NO BLOOD TRANSFUSION WAS REQUIRED. IT WASSAID THAT THE IMPLANTED DEFECTIVE CATHETER WAS EXPLANTED ON THE SAME DAY AND WAS REPLACED WITH A NEW ONE (DIFFERENT LOT) AS INTERVENTION AND TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568688 ↗
• MalfunctionOct 30, 2020Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE PATIENT WAS PREPARED FOR CATHETER INSERTION AND WHILE FLUSHING THE CATHETER BEFORE INSERTION, THE CAT HETER'S THIRD LUMEN (MEDICAL LINE) WAS FOUND TO BE BLOCKED (THE BLOCKAGE WAS FOUND ON THE CATHETER SHAFT. )THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. NO CLEANING AGENT WAS USED ON THE DEVICE; IT WAS ONLY FLUSHED WITH NORMAL SALINE (NS). TEGO WAS NOT UTILIZED. AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO DAMAGE TO THE DEVICE'S BOX AND PACKAGING. THE PRODUCT/KIT WAS STILL SEALED UPON RECEIPT, AND NO EXCESSIVE FORCE WAS USED TO PULL/TAKE OUT THE PRODUCT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, AND THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT, AND NO INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THE CATHETER WAS NO LONGER USED ON THE PATIENT. THE DOCTOR HAD TO USE ANOTHER CATHETER FROM THEIR STOCK AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 10762001 ↗
• MalfunctionJul 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IT WAS STATED THAT THE LUER ADAPTER IN THE MIDDLE LINE OF TRIPLE LUMEN WAS FOUND DETACHED IN THE FRESH PACK, ANOTHER FRESH PACK HAD THE SAME ISSUE. CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. A DEVICE WAS USED TO CLEAN THE DEVICE, TEGO WAS NOT UTILIZED. IT WAS REPORTED THAT A NEW CATHETER WAS OPENED TO DO THE PROCEDURE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE DEVICE WAS NOT INSERTED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10321089 ↗
• MalfunctionJul 17, 2019Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, AFTER THE PROCEDURE, THE CATHETER HAD A KINKING ISSUE. IT WAS NOT REPAIRED AND THERE WAS NO LEAK. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT AND CHLORHEXIDINE WAS USED AS A CLEANING AGENT ON THE DEVICE. THERE WAS NO PACKAGING DAMAGE AND FLUSHING WAS DONE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND THE PATIENT WAS TREATED UNDER LOCAL ANESTHESIA. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE AND NO OTHER DEFECTS WERE FOUND. THEY HAD TO REPLACE THE CATHETER WITH A NEWER ONE TO RESOLVE THE ISSUE AND IT WAS USED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8800458 ↗
• MalfunctionFeb 18, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, ON INSERTION ON RIGHT INTERNAL JUGULAR VEIN, AFTER INSERTION AND FLUSHING ALL THE PORTS, BLOOD KEPT ON COMING BACK FROM THE 3RD LUMEN (CENTRAL VENOUS ACCESS/DRUG PORT) INSPITE OF BLOCKING THE LINE WITH THE LOCK PROVIDED ON THE PORT. WHILE ALSO FLUSHING, IT WAS ALSO FOUND THAT THE PORT WAS LEAKING AT ITS ENTRY POINT FAR AWAY FROM THE LOCK, AT THE JUNCTION OF EXTENSION TUBE AND BIFURCATE. THE CATHETER WAS CHANGED WITH A NEW ONE AND WAS REPORTED TO WORK FINE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8347239 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020089, K192302. One submission often covers many models, so check the product and lot details in each record.

• 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-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-0422-2026 · 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 16 cm;
• 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-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-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-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-2372-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
• 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-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
• Z-2390-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637
• Z-2388-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629
• Z-2371-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 8888102003HP
• Z-2381-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637HP

…and 16 more.