ARROW IPN030105Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801902100177), received between Aug 13, 2024 and Oct 20, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT "SWG UNRAVELED." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 23335016 ↗
• MalfunctionMar 31, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT "GUIDE WIRE INITIALLY WENT SMOOTHLY IN, ON THREADING THE CATHETER THERE WAS A RESISTANCE SO THE CATHETER WAS WI THDRAWN TO TRY AND RE-THREAD IT BUT THE WIRE WAS FOUND TO BE KINKED AND THEN ON WITHDRAWAL OF THE GUIDEWIRE IT WAS KINKED AND IT WAS COMPLETELY WITHDRAWN ONE PIECE BUT WITH SOME UNCOILING OF THE OUTER PART (ALL THE PARTS CAME OUT, ONE PIECE). THEN A SECOND ATTEMPT WAS DONE WITH A NEW SET, AND IT WENT IN SMOOTH WITH NO ISSUES.". THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731636 ↗
• MalfunctionMar 26, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT "DIALYSIS CATHETER WAS PLACED IN ICU, THE GUIDEWIRE KINKED INSIDE THE CATHETER, UPON REMOVAL OF THE CATHETER, THE WIRE & COIL SEPARATED. A SECOND CATHETER WAS OPENED AND INSERTED SUCCESSFULLY.". ADDITIONAL INFORMATION FROM THE CLINICAL STAFF INDICATED THAT THE PATIENT PASSED AWAY A FEW DAYS LATER, UNRELATED TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698181 ↗
• MalfunctionNov 15, 2024Obstruction of Flow; Output Problem; Obstruction of Flow; Output Problem

  IT WAS REPORTED "AFTER THE INSERTION OF ACUTE ANTIMICROBIAL DIALYSIS CATHETER TO THE PATIENT, THE CATHETER WORKED WELL FOR 2 HOURS. AFTER 2 HOURS THE VENUS LUMEN (BLUE ONE) DID NOT WORKED WELL, INABILITY TO RETURN AND DIFFICULTY IN THE OUTPUT WHICH GRADUALLY STOPPED WORKING. THE LUMEN BLOCKED AND IT WAS NOT POSSIBLE TO CONTINUE THE DIALYSIS. WE CHANGED THE CATHETER AND THE POSITION OF THE CATHETER INSERTION (FEMORAL, SUBCLAVIAN, JUGULAR). THE SAME INCIDENT (VENUS LUMEN STOPPED WORKING AFTER 2 HOURS) OCCURRED IN OTHER 3 DIALYSIS CATHETERS IN THE SAME PATIENT WHICH INTRODUCED IN DIFFERENT VESSELS (FEMORAL, SUBCLAVIAN)." THERE WAS NO MEDICAL INTERVENTION REQUIRED. IT WAS REPORTED "HE DIED 9 DAYS AFTER THE CARDIAC SURGERY. PATIENT WAS IN CRITICAL CONDITION PRIOR TO USE OF THE DEVICE." ADDITIONAL INFORMATION RECEIVED STATES "THE DEVICE IS NOT ASSOCIATED WITH THE PATIENTS DEATH." ASSOCIATED MDR NUMBER INCLUDES: 3006425876-2024-01112, 3006425876-2024-01111, 3006425876-2024-01110.

  Patient problems: Insufficient Information

  MAUDE report 20695160 ↗
• MalfunctionAug 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "ARS LEAKING AIR. PATIENT IS FINE/NO PATIENT HARM." THE USER CHANGED TO A NEW SET. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19976907 ↗

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