ARROW IPN030114Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801902100191), received between Sep 16, 2021 and Jan 14, 2025 — classified as 1 death, 7 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (5 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 14, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT "DURING THE PROCEDURE, THE GUIDEWIRE WAS DAMAGED: WHILE BEING INSERTED THROUGH THE NEEDLE, THE DISTAL SECTION OF THE METAL BRAID ON THE GUIDEWIRE UNRAVELLED, MAKING IT IMPOSSIBLE TO CONTINUE ITS INSERTION OR REMOVE IT FROM THE NEEDLE'S LUMEN. THE ENTIRE ASSEMBLY WAS REMOVED, AND A NEW, DIFFERENT GUIDEWIRE WAS USED. A SECOND VENOUS PUNCTURE WAS REQUIRED. THE PATIENT WAS UNHARMED, AND THE CATHETER WAS SUCCESSFULLY IMPLANTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148897 ↗
• MalfunctionOct 2, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: THE CATHETER MALFUNCTIONED DURING DIALYSIS. THE FLOW LINES WERE CONNECTED PROPERLY. BUT THE ALARM RANG. DESPITE REVERSING THE LINES, THE FLOW REMAINED INSUFFICIENT. THE VOLUME OF BLOOD TREATED WAS INSUFFICIENT. IT WAS REPORTED THAT THERE WAS A POOR PURIFICATION BLOOD QUALITY BECAUSE OF THE ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ACCOUNT REGARDING THE CONDITION OF THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17849925 ↗
• DeathSep 29, 2023Mechanical Problem; Mechanical Problem

  COMPLAINT FROM HOSPITAL REPORTS: "IN RESPONSE TO EMERGENCY ALARM BEING TRIGGERED IN BED SPACE. ATTENDED TO FIND PATIENT UNRESPONSIVE, HYPOXIC, AND BRADYCARDIC AND HYPOTENSIVE. HAD RECENTLY BEEN DISCONNECTED FROM HEMOFILTRATION MACHINE, LIKELY AIR EMBOLI." THE BEDSIDE NURSE REPORTED "SHE HAD CLAMPED BOTH ACCESS AND RETURN LINE WHEN SHE WAS REQUIRED TO DISCONTINUE FILTRATION TREATMENT DUE TO A WATER INSUFFICIENCY. SHE THEN ATTENDED TO THE MACHINE, ON RETURN TO THE PATIENT SHE FOUND HIM GASPING AND UNRESPONSIVE. SHE NOTED THAT BLOOD WAS COMING OUT OF THE BLUE RETURN LINE AND IT WAS NO LONGER CLAMPED. SHE IMMEDIATELY RE-CLAMPED IT AND ALERTED THE EMERGENCY CALL BELL." IT WAS REPORTED THE PATIENT WAS POSITIONED HEAD DOWN, GIVEN METER AMINOL BOLUS DOSES AND FLUID BOLUS. PATIENT WAS INTUBATED, VENTILATED WITH 100% O2, HAD CARDIOVASCULAR INSTABILITY, WAS SEVERELY HYPOTENSIVE, AND GIVEN ADRENALINE 1MG BOLUS DOSES. "CVC LINE SITED FOR ADDITIONAL MEDICATIONS. SEDATION COMMENCED. STABILITY ACHIEVED". A BEDSIDE ECHO SHOWED GLOBAL POOR CONTRACTION AND BRADYCARDIA AT 40 BPM, NO RV DILATION OR STRAIN, AND ECHO BUBBLES IN RV AND RA (NO CENTRAL FLUID RUNNING AT THE TIME). IT WAS REPORTED THE PATIENT

  Patient problems: Air Embolism; Bradycardia; Hypoxia; Low Blood Pressure/ Hypotension

  MAUDE report 17842154 ↗
• MalfunctionAug 23, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "DYSFUNCTIONAL CATHETER. PUMP STOPPED SEVERAL TIMES. LINES REVERSED AND INSUFFISANT LOW FLOW RATE." ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 17606443 ↗
• MalfunctionAug 23, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "DYSFUNCTIONAL CATHETER. PUMP STOPPED SEVERAL TIMES. LINES REVERSED AND INSUFFICIENT LOW FLOW RATE." ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 17606155 ↗
• MalfunctionAug 23, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "DYSFUNCTIONAL CATHETER. PUMP STOPPED SEVERAL TIMES. LINES REVERSED AND INSUFFISANT LOW FLOW RATE." ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 17605881 ↗
• MalfunctionAug 23, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "DYSFUNCTIONAL CATHETER. PUMP STOPPED SEVERAL TIMES. LINES REVERSED AND INSUFFISANT LOW FLOW RATE." ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 17605502 ↗
• MalfunctionSep 16, 2021Unraveled Material; Unraveled Material

  IT WAS REPORTED THE PHYSICIAN WAS PLACING THE CATHETER IN THE PATIENT'S LEFT JUGULAR VEIN AND THE GUIDEWIRE UNRAVELLED MAKING IT DIFFICULT TO REMOVE. THE GUIDEWIRE WAS SUCCESSFULLY REMOVED, BUT WITH A LOT OF "TEASING" IT OUT TO STOP IT UNRAVELLING FURTHER. THERE WAS NO PATIENT HARM. HEMOFILTRATION STARTED AS PLANNED AND NO ADDITIONAL MEDICAL TREATMENT WAS REQUIRED. IT WAS REPORTED THERE WAS SIGNIFICANT BLOOD LOSS THROUGH THE CATHETER, ABOUT 200ML, BECAUSE IT WASN'T POSSIBLE TO REMOVE THE WIRE EASILY OR QUICKLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12484575 ↗

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