ARROW IPN033100Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10801902096583), received between Dec 8, 2023 and Jan 7, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 reports).

5 other recalls cover devices cleared under the same FDA submission (K993933); 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 16, 2026.

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.

• MalfunctionJan 7, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "(B)(6) 2025, WHEN TEACHER FROM THE (B)(6) WAS USING IT, THE GUIDEWIRE WAS FOUND KINKED. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED. INVOLVED 1 PC."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987852 ↗
• MalfunctionAug 5, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "AN INCIDENT OCCURRED WITH THE SAME LINE. FOR THIS INCIDENT THERE WAS NO CONSEQUENCE FOR THE PATIENT. THE DEVICE WAS DISCARDED. THERE WAS THE TRIGGER OF THE "AIR BUBBLE" ALARM (LEAK)." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBER INCLUDES: 3006425876-2025-00715 AND 9680794-2025-00648.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714287 ↗
• MalfunctionFeb 8, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT: INCIDENT OCCURRED ON (B)(6) 2024, INVOLVED A 71-YEAR-OLD FEMALE PATIENT. PATIENT IN INTENSIVE CARE UNIT WITH ACUTE RENAL FAILURE AND HYPERLACTATEMIA. THE PATIENT HAD BEEN ON DIALYSIS FOR 3.5 HOURS, USING AN AV-SET-ONLINE PLUS 5008-R DIALYSIS CIRCUIT (FROM ANOTHER SUPPLIER) CONNECTED TO A FEMORAL 2V 12FR X 25CM 12G/12G ST HEMODIALYSIS CATHETER FROM TELEFLEX. WHEN THE DIALYSIS WAS DISCONNECTED FROM THE TELEFLEX CATHETER FOR A SCAN EXAMINATION, THE BLUE PART OF THE CIRCUIT REMAINED "STUCK" INSIDE THE BLUE PART OF THE CATHETER. THE CIRCUIT BROKE, LEAVING THE CONNECTOR INSIDE THE CATHETER. THERE WERE NO CLINICAL CONSEQUENCES, BUT THE PATIENT'S DIALYSIS CATHETER HAD TO BE CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667955 ↗
• MalfunctionJan 4, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: HEMODIALYSIS CATHETER INSERTED UNDER ULTRASOUND GUIDANCE INTO THE RIGHT FEMORAL VEIN. DURING CANNULATION, THEY USED AN INTRODUCER NEEDLE. INSERTED SWG AFTER SYRINGE DISCONNECTION. THE CATHETER IS PLACED ALONG THE SWG. AS THE SWG IS REMOVED THROUGH THE CATHETER. THERE IS RESISTANCE. THE SWG WAS PULLED OUT WITH FORCE (BEING CAREFUL NOT TO DAMAGE THE VESSEL). THE END OF THE GUIDE TAKES THE SHAPE OF A "PIG'S TAIL", A "COILED SPRING". CLINICAL CONSEQUENCES: THE CATHETER IS BLOCKED AFTER THIS. THIS CATHETER MUST BE REMOVED AND THE HEMODIALYSIS CATHETER PLACED ELSEWHERE. THIS SITUATION OCCURRED THREE TIMES IN THE WARD. 3 DIFFERENT OPERATORS, 3 DIFFERENT PATIENTS. PHOTOS ATTACHED SHOWED THAT THE CATHETER WAS BENT. ASSOCIATED COMPLAINTS (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18442166 ↗
• MalfunctionJan 4, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: HEMODIALYSIS CATHETER INSERTED UNDER ULTRASOUND GUIDANCE INTO THE RIGHT FEMORAL VEIN. DURING CANNULATION, THEY USED AN INTRODUCER NEEDLE. INSERTED SWG AFTER SYRINGE DISCONNECTION. THE CATHETER IS PLACED ALONG THE SWG. AS THE SWG IS REMOVED THROUGH THE CATHETER. THERE IS RESISTANCE. THE SWG WAS PULLED OUT WITH FORCE (BEING CAREFUL NOT TO DAMAGE THE VESSEL). THE END OF THE GUIDE TAKES THE SHAPE OF A "PIG'S TAIL", A "COILED SPRING". CLINICAL CONSEQUENCES: THE CATHETER IS BLOCKED AFTER THIS. THIS CATHETER MUST BE REMOVED AND THE HEMODIALYSIS CATHETER PLACED ELSEWHERE. THIS SITUATION OCCURRED THREE TIMES IN THE WARD. 3 DIFFERENT OPERATORS, 3 DIFFERENT PATIENTS. PHOTOS ATTACHED SHOWED THAT THE CATHETER WAS BENT. ASSOCIATED COMPLAINTS (B)(6).

  Patient problems: Insufficient Information

  MAUDE report 18442152 ↗
• MalfunctionDec 8, 2023Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT " HEMODIALYSIS CATHETER INSERTED UNDER ULTRASOUND GUIDANCE INTO THE RIGHT FEMORAL VEIN. DURING CANNULATION, THEY USED AN INTRODUCER NEEDLE. INSERT SWG AFTER SYRINGE DISCONNECTION. THE CATHETER IS PLACED ALONG THE SWG. AS THE SWG IS REMOVED THROUGH THE CATHETER. THERE IS RESISTANCE. THE SWG WAS PULLED OUT WITH FORCE. THE END OF THE GUIDE TAKES THE SHAPE OF A "PIG'S TAIL", A "COILED SPRING". ASSOCIATED COMPLAINTS; 3006425876-2023-01206. 3006425876-2023-01205.

  Patient problems: Insufficient Information

  MAUDE report 18289970 ↗
• MalfunctionDec 8, 2023Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT " HEMODIALYSIS CATHETER INSERTED UNDER ULTRASOUND GUIDANCE INTO THE RIGHT FEMORAL VEIN. DURING CANNULATION, THEY USE A INTRODUCER NEEDLE. INSERT SWG AFTER SYRINGE DISCONNECTION. THE CATHETER IS PLACED ALONG THE SWG. AS THE SWG IS REMOVED THROUGH THE CATHETER. THERE IS RESISTANCE. THE SWG WAS PULLED OUT WITH FORCE. THE END OF THE GUIDE TAKES THE SHAPE OF A "PIG'S TAIL", A "COILED SPRING". ASSOCIATED COMPLAINTS: 3006425876-2023-01207, 3006425876-2023-01206, 3006425876-2023-01205.

  Patient problems: Insufficient Information

  MAUDE report 18289951 ↗
• MalfunctionDec 8, 2023Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT: 2 DIFFERENT OPERATORS TRIED TO PASS THE SWG THROUGH THE INTRODUCER NEEDLE BUT THERE WAS RESISTANCE. THE GUIDE UNRAVELLED AND IT WAS IMPOSSIBLE TO PASS THE GUIDE INTO THE VESSEL. ASSOCIATED COMPLAINTS: 3006425876-2023-01207, 3006425876-2023-01206, 3006425876-2023-01205.

  Patient problems: Insufficient Information

  MAUDE report 18289927 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K993933. One submission often covers many models, so check the product and lot details in each record.

• Z-2373-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122; HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC; HEMODIALYS
• Z-1336-2018 · Dec 22, 2017 · Terminated
  ARROWg+ard Blue Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1
• Z-0658-2018 · Oct 17, 2017 · Terminated
  ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2
• Z-2334-2017 · May 9, 2017 · Terminated
  1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits venous access to the central circulation
• Z-0639-04 · Feb 18, 2004 · Terminated
  Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions