ARROW IPN030108Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801902102188), received between Jan 28, 2021 and Dec 4, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "(B)(6) 2025, IN (B)(6) HOSPITAL, THE DOCTOR FOUND THE SWG KINKED AND CAN'T USE." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715454 ↗
• MalfunctionOct 2, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT " ON (B)(6) 2025, DURING INSERTION THE DOCTOR FOUND THE SWG TIP KINKED DURING TO THE PATIENT. THE SWG CAN'T BE INSERTED INTO ARS." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. 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 23199274 ↗
• MalfunctionApr 16, 2025Material Separation; Material Separation

  IT WAS REPORTED "ONE OF SET LUER-HUB BROKEN. ONE OF SET GUIDE WIRE BROKEN." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATES THE LUER HUB WAS " SEPARATED FROM THE EXTENSION LINE". THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE:3006425876-2025-00376 AND 3006425876-2025-00375.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21847192 ↗
• MalfunctionApr 16, 2025Material Separation; Material Separation

  IT WAS REPORTED "ONE OF SET LUER-HUB BROKEN. ONE OF SET GUIDE WIRE BROKEN." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATES THE GUIDE WIRE WAS " SEPARATED IN TWO PIECES". THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE:3006425876-2025-00376 AND 3006425876-2025-00375.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21847165 ↗
• MalfunctionApr 16, 2025Crack; Crack

  IT WAS REPORTED "ON THE 19TH MARCH 2025, IN NEURO ICU (B)(6) HOSPITAL, THE DOCTOR WAS INSERTING A LARGE BORE CATHETER TO THE PATIENT AND A NEEDLE HUB HAD A CRACK, WHEN HE ATTACHED THE NEEDLE TO SYRINGE, THE HUB BROKE." THIS WAS FOUND PRIOR TO USE. THE USER CHANGED TO A NEW SET. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21846591 ↗
• MalfunctionApr 11, 2025Unraveled Material; Material Twisted/Bent; Unraveled Material; Material Twisted/Bent

  IT WAS REPORTED "ON (B)(6) 2025, (B)(6) HOSPITAL ICU, THE DOCTOR (B)(6) FOUND THE SWG KINKED DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. 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 21825175 ↗
• MalfunctionMar 7, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "THE DOCTOR DESCRIBED THE SWG CAN'T INSERTED INTO THE CATHETER, THEY SUSPECTED THE CATHETER BLOCK DURING USED ON THE PATIENT.". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21548048 ↗
• MalfunctionFeb 13, 2025Crack; Crack

  IT WAS REPORTED THAT "DURING INSERTION OF THE CVC WHEN THE PHYSICIAN TRIED TO ASPIRATE, HE THEN NOTICED THERE WAS AIR ESCAPING FROM THE HUB OF THE NEEDLE. UPON INVESTIGATION OF THE INTRODUCER NEEDLE IT WAS NOTICED THAT THERE IS A CRACK ON THE NEEDLE HUB. ANOTHER NEW CVC SET OPENED TO COMPLETE THE PROCEDURE". THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374125 ↗
• MalfunctionJan 30, 2025Break; Break

  IT WAS REPORTED THAT DURING OF INSERTION OF HD CATHETER, THE DILATOR TIP WAS FOUND BROKEN. THE PATIENT IS FINE AND HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273828 ↗
• MalfunctionOct 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE EXTENSION LINE LEAKING DURING USE ON THE PATIENT. THEY CHANGED A NEW ONE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471001 ↗
• MalfunctionMay 1, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED "IN THE EMERGENCY, THE DOCTOR FOUND THE SWG KINKED DURING USED ON THE SAME PATIENT." NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE 3006425876-2024-00381.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220296 ↗
• MalfunctionMay 1, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED "IN THE EMERGENCY, THE DOCTOR FOUND THE SWG KINKED DURING USED ON THE SAME PATIENT." NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE 3006425876-2024-00383.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219831 ↗
• MalfunctionMar 28, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE FRONT OF THE INTRODUCER NEEDLE FOR DILATOR INSERTION IS BENT SKEWED, MAKING IT IMPOSSIBLE TO PASS THROUGH NORMALLY." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEY WERE REPROTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991176 ↗
• MalfunctionMar 28, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE FRONT OF THE INTRODUCER NEEDLE FOR DILATOR INSERTION IS BENT/SKEWED, MAKING IT IMPOSSIBLE TO PASS THROUGH NORMALLY." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEY WERE REPROTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18990989 ↗
• MalfunctionFeb 2, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT" (B)(6) 2024, THE DOCTOR FOUND SWG KINKED DURING USED ON THE PATIENT. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18629912 ↗
• MalfunctionAug 13, 2023Unraveled Material; Unraveled Material

  IT WAS REPORTED THE SPRING WIRE GUIDE (SWG) UNRAVELED WHEN REMOVING THE GUIDEWIRE FROM THE CATHETER IN THE VESSEL. THE INSERTION SITE WAS THE SUBCLAVIAN VEIN AND THE VESSEL WAS TORTUOUS. IT WAS REPORTED THE GUIDEWIRE WAS "REMOVED ENTIRETY AND NOT WITH ANY INTERVENTION PERFORMED, JUST SLOWLY PULLED OUT". THE DEVICE WAS REPLACED AND A SECOND ATTEMPT WAS SUCCESSFUL AT THE SAME INSERTION SITE. NO PATIENT INJURY WAS REPORTED. IT WAS REPORTED "THE PATIENT WAS EXPIRED UNFORTUNATELY, NOT BECAUSE OF THE UNRAVELED SWG".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538011 ↗
• MalfunctionApr 29, 2022Material Separation; Unraveled Material; Physical Resistance/Sticking; Material Separation; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED DURING CATHETER INSERTION, IT WAS DIFFICULT TO ADVANCE THE CATHETER THROUGH THE WIRE. THERE WAS NO KINK IN THE WIRE VISIBLE. WHEN ATTEMPTING TO RETHREAD THE CATHETER, THE WIRE COULD NO LONGER BE MOVED. AFTER SOME INCREASED TENSION ON THE WIRE, THE WIRE BROKE. THE CATHETER AND WIRE WERE REMOVED FROM THE PATIENT AND A NEW SET WAS USED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION WAS REPORTED AS CRITICAL UNRELATED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14249954 ↗
• MalfunctionJan 28, 2021Unraveled Material; Unraveled Material

  THE COMPLAINT IS REPORTED AS: THE SPRING WIRE GUIDE UNRAVELED WHEN PULLING IT OUT. NO PATIENT INJURY OR COMPLICATION REPORTED. THE DEVICE WAS REPLACED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11247786 ↗

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-1985-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2
• 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-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