ARROW IPN030943Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10801902028560), received between Jan 27, 2021 and Nov 18, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Break; Break

  IT WAS REPORTED THAT: "DURING INSERTION OF ARROW BILUMEN CENTRAL VENOUS CATHETER REFERENCE CV-26702-E VIA THE LEFT SUBCLAVIAN VEIN, PARTIAL BREAKAGE OF THE GUIDE OCCURS AT THE MOMENT OF REMOVAL, 7 CM FROM THE CURVED TIP." THE GUIDE WAS REMOVED. 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 23582427 ↗
• MalfunctionJun 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PATIENT IS RECEIVED IN REGULAR GENERAL CONDITIONS, WITH REQUIREMENT OF OROTRACHEAL INTUBATION AND PASSAGE OF BILUMEN CENTRAL CATHETER WHICH IS PERFORMED SUCCESSFULLY, THEN TEST IS PERFORMED WITH A 20 CUBIC CENTIMETER SYRINGE WITH NORMAL SALINE SOLUTION AND LIQUID LEAKAGE IS EVIDENCED BY THE PROXIMAL VIA INFORMS THE PHYSICIAN ON DUTY, WHO IMMEDIATELY PROCEEDS TO PERFORM CATHETER CHANGE AND RADIOLOGICAL CONTROL." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143768 ↗
• MalfunctionDec 12, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT "A PATIENT UNDERGOING CENTRAL VENOUS CATHETER PLACEMENT EXPERIENCED AN ISSUE WHERE THE GUIDEWIRE BECAME STUCK WHILE ATTEMPTING TO REMOVE IT FROM THE FEMORAL VEIN. UPON SUCCESSFUL REMOVAL, IT WAS OBSERVED THAT THE TIP OF THE GUIDEWIRE WAS COILED". THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20915979 ↗
• MalfunctionAug 29, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "AT 16:30, AFTER HAND WASHING AND USING PERSONAL PROTECTIVE EQUIPMENT WITH STERILE TECHNIQUE, THE AREA WAS CLEANED AT THE LEVEL, SUPRA AND INFRACLAVICULAR LEFT WITH CHLORHEXIDINE SOAP AND SOLUTION. THE ON-DUTY DOCTOR WAS ASSISTED, WHO ADVANCED A DOUBLE-LUMEN CENTRAL VENOUS CATHETER ON THE FIRST PUNCTURE. PEEP WAS DECREASED TO AVOID PNEUMOTHORAX. THE CATHETER WAS ADVANCED WITH THE SELDINGER TECHNIQUE WITHOUT EVIDENCE OF CARDIAC STIMULATION DURING THE ADVANCEMENT OF THE METAL GUIDE. AT THE TIME OF INSERTION, IT WAS EVIDENT THAT ONE OF THE LINES WAS BROKEN (DISTAL 16 GA), SO THE DOUBLE-LUMEN CENTRAL VENOUS CATHETER WAS CHANGED. THE INSERTION SITE SHOWED NO HEMATOMA, WAS COVERED WITH GAUZE AND A TRANSPARENT DRESSING, AND LABELED ACCORDING TO INSTITUTIONAL PROTOCOL (START DATE AND RESPONSIBLE PERSON). THERAPY WAS NOT DELAYED OR INTERRUPTED. THERE WERE NOT PATIENT COMPLICATIONS.

  Patient problems: Insufficient Information

  MAUDE report 20093602 ↗
• MalfunctionMar 7, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE DOCTOR REPORTS THAT THE METAL GUIDE IS BENT, HE IDENTIFIES IT BEFORE USING IT ON THE PATIENT, HE USES ANOTHER DEVICE." THE PATIENT WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18855825 ↗
• MalfunctionOct 9, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED DURING INSERTION OF A BILUMEN CENTRAL VENOUS CATHETER, THE GUIDEWIRE "BENDS AS THE CATHETER ADVANCES". NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17897319 ↗
• MalfunctionJan 27, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE COMPLAINT IS REPORTED AS: "A CVC PASSAGE IS ATTEMPTED, WHICH IS NOT POSSIBLE BECAUSE THE METALLIC GUIDE IS BENDED". NO PATIENT INJURY OR COMPLICATION REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11240376 ↗

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 ac
• 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