ARROW IPN032930Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902099263), received between Nov 30, 2023 and Sep 2, 2024 — classified as 1 injury, 3 malfunctions.

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

12 other recalls cover devices cleared under the same FDA submission (K900263); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT: "(B)(6) 2024, THE SWG CAN'T GO THROUGH THE ARS DUE TO THE THIN INSIDE OF ARS. THE ISSUE WAS IDENTIFIED PRIOR TO THE PATIENT. THEY COMPLAINT THE NEEDLE CANNULA IS TOO THIN FOR THE ARS. INVOLVED 1 PC."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20118155 ↗
• MalfunctionFeb 8, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT "13 DEC 2023, THE DILATOR TIP WAS FOUND DAMAGED DURING USE ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669422 ↗
• MalfunctionJan 29, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE DOCTOR FOUND THE SWG KINKED DURING USED ON THE PATIENT". NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUEST FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18601204 ↗
• InjuryNov 30, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT: (B)(6) 2023, AFTER CATHETERIZATION IN THE SURGICAL CENTRE, BLOOD PRESSURE DECREASED, SKIN TURNED RED, AND ALLERGIC SHOCK OCCURRED. AFTER RECEIVING VASOACTIVE DRUGS AND ANTI-ALLERGIC THERAPY TO REPLENISH BLOOD VOLUME, HORMONE THERAPY, AND OTHER TREATMENTS, THE PATIENT'S VITAL SIGNS GRADUALLY STABILIZED BEFORE UNDERGOING SURGERY. THE VITAL SIGNS REMAINED STABLE DURING THE SURGERY AND PATIENT WAS RETURNED TO THE WARD AFTER THE SURGERY. THERE WAS A DELAY TO SURGERY BUT PATIENT WAS REPORTED AS GOOD POST THE PROCEDURE.

  Patient problems: Anaphylactoid / Anaphylaxis; Erythema; Low Blood Pressure/ Hypotension

  MAUDE report 18235672 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K900263. One submission often covers many models, so check the product and lot details in each record.

• Z-2376-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-
• Z-0053-2020 · May 17, 2019 · Terminated
  Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous acces
• Z-2886-2018 · Jul 3, 2018 · Terminated
  Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous acc
• Z-1984-2018 · Apr 11, 2018 · Terminated
  Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter and Sharps Safety Features; Product Code: ASK-24306-VC
• Z-1985-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2
• Z-1333-2018 · Dec 22, 2017 · Terminated
  ARROWg+ard Blue CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit, PN: CDC-22123-1A; (4) Central Venous Catheter
• Z-1001-2018 · Nov 27, 2017 · Terminated
  ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or condi
• Z-2337-2017 · May 9, 2017 · Terminated
  ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation
• Z-1830-2012 · May 3, 2012 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circ
• Z-2496-2010 · Jul 29, 2010 · Terminated
  Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter
• Z-1499-2009 · Feb 11, 2009 · Terminated
  Arrow ARROWg+ard CVCs (Central Venous Catheters)
• Z-0082-04 · Sep 16, 2003 · Terminated
  Arrow Howes multi-lumen central venous catheterization kit 7 Fr x 20 cm