ARROW IPN030165Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801902102331), received between Sep 1, 2023 and Mar 9, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Crack” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Crack

  IT WAS REPORTED THAT "(B)(6) 2026, AFTER CHECKING BEFORE USING, THE NEED HUB WAS FOUND CRACK PRIOR TO THE PATIENT." THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545666 ↗
• MalfunctionFeb 24, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT "THE DEPARTMENT REPORTED A CRACK IN THE TRANSPARENT PLASTIC AREA AT THE FRONT END OF THE ARS NEAR THE NEEDLE TIP, WHICH CAUSED LEAKAGE OF BLOOD REFLUX ." THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428657 ↗
• MalfunctionJul 8, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED "AN UNKNOWN WHITE FOREIGN OBJECT WAS FOUND INSIDE THE TUBING AT THE TIP END OF THE CVC SET. DUE TO SURGICAL NEEDS, THE CVC WAS INSERTED IN THE OPERATING ROOM ON JUNE 10. ON JUNE 11, AN X-RAY REVEALED A CLEAR RADIOPAQUE AREA AT THE TIP END OF THE CVC. AFTER CONFIRMATION BY THE PHYSICIAN, IT WAS VERIFIED THAT THIS WAS NOT A RETAINED GUIDEWIRE. ON JUNE 12, THE CVC WAS REMOVED FROM THE PATIENT, AND A FURTHER X-RAY CONFIRMED A DISTINCT RADIOPAQUE SEGMENT AT THE TIP END. UPON CUTTING OPEN THE TUBING, AN UNKNOWN WHITE FOREIGN OBJECT WAS FOUND INSIDE ONE OF THE LUMENS." THE USER CHANGED TO A NEW SET. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436533 ↗
• MalfunctionMar 20, 2025Migration; Migration

  IT WAS REPORTED THAT "CATHETER SLIP".

  Patient problems: Insufficient Information

  MAUDE report 21650570 ↗
• MalfunctionJan 30, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "WHEN ATTEMPTED TO REMOVE THE GUIDEWIRE FROM THE 2-WAY CVC, RESISTANCE WAS ENCOUNTERED. UPON REMOVAL, THE KINKS WERE FOUND ON THE WIRE". THE PATIENT IS HARM AND HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273073 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED, "AFTER ANESTHESIA, THE PATIENT WAS CATHETERIZED BY RIGHT DEEP VEIN PUNCTURE, AND AFTER CATHETER PLACEMENT, THE PATIENT'S INVASIVE ARTERIAL BLOOD PRESSURE APPEARED TO DROP SIGNIFICANTLY, FROM 115/59 MMHG TO 52/35 MMHG, AND THE PATIENT'S BLOOD PRESSURE ROSE WITH REPEATED MULTIPLE INTRAVENOUS PUSHES OF EPINEPHRINE AT 10UG/ML, AND SUBCUTANEOUS INJECTIONS OF EPINEPHRINE AT 0.3 MG INTO THE LEFT SHOULDER, AND THE PATIENT REPEATEDLY DEVELOPED RECURRENT INTRACTABLE HYPOTENSION. THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER BRAND OF DEEP VENOUS CATHETER." ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 20031107 ↗
• MalfunctionMay 8, 2024Crack; Crack

  IT WAS REPORTED "THE LUER HUB WAS FOUND CRACK DURING USE ON THE PATIENT." THE CUSTOMER CHANGED TO A NEW SET. NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19272323 ↗
• MalfunctionMay 1, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT " SWG RESISTANCE/HARD TO ADVANCE. NO ADVERSE REACTION OCCURRED IN A PATIENT." THE RETURNED DEVICE WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220900 ↗
• MalfunctionMar 29, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT " SWG KINKED. USED ANOTHER NEW SET TO COMPLETE THE PROCEDURE. USED ON A PATIENT BUT NO PATIENT HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002075 ↗
• MalfunctionJan 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: SLIDE CLAMPS LOOSE AND THEN MISSING, A CATHETER OCCLUSION AND REMOVAL. ADDITIONAL INFORMATION: THE CVC WAS FOUND OBSTRUCTED IN THE LUMEN WITH A CLAMP MISSING. CVC WAS REPLACED. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18501728 ↗
• MalfunctionJan 12, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: SLIDE CLAMPS LOOSE AND THEN MISSING, A CATHETER OCCLUSION AND REMOVAL. ADDITIONAL INFOMRATION: THE CVC WAS FOUND OBSTRUCTED IN THE LUMEN WITH A CLAMP MISSING. CVC WAS REPLACED. THERE WAS NO REPORTED PATIENT HARM. ASSOCIATED TO 3006425876-2024-00067.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18501727 ↗
• MalfunctionDec 27, 2023Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT "THE ARS WAS FOUND DAMAGED DURING USED ON THE PATIENT". NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18401333 ↗
• MalfunctionSep 1, 2023Break; Unraveled Material; Break; Unraveled Material

  IT WAS REPORTED THAT "THE SWG (SPRING WIRE GUIDE) WASN'T TAKEN OUT SMOOTHLY, AND IT WAS BROKEN & UNRAVELED AFTER BEING PULLED OUT FORCIBLY." THE DEVICE WAS REMOVED IN ITS ENTIRETY AND REPLACED. NO PATIENT HARM WAS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670821 ↗

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