ARROW IPN030773Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 40801902127714), received between Aug 7, 2023 and Aug 6, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (9 reports).

24 other recalls cover devices cleared under the same FDA submission (K862056); 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.

• MalfunctionAug 6, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "(B)(6) 2025, DURING INSERTION, THE DOCTOR FOUND THE SWG KINKED DURING USE ON THE PATIENT." THE USER WITHDREW THE SWG AND CHANGED TO A NEW ONE. 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 22730183 ↗
• MalfunctionJun 25, 2025Crack; Crack

  IT WAS REPORTED THAT "THE PLASTIC TIP OF THE CANNULA IS BROKEN OR CRACKED." NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00572.

  Patient problems: Insufficient Information

  MAUDE report 22328724 ↗
• MalfunctionJun 25, 2025Crack; Crack

  IT WAS REPORTED THAT "THE PLASTIC TIP OF THE CANNULA IS BROKEN OR CRACKED." ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00578.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328490 ↗
• MalfunctionApr 15, 2025Crack; Crack

  IT WAS REPORTED "WHEN THE SYRINGE IS GENTLY PUSHED ONTO THE LUER CONNECTOR, THE PUNCTURE CANNULA CAN BECOME HAIRLINE CRACKED OR SPLINTER COMPLETELY. IN ONE CASE, THE CANNULA WAS ALREADY DEFECTIVE WHEN UNPACKED." THIS EVENT OCCURED PRIOR TO USE. THERE WAS NO PATIENT HARM OR INJURY. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00371, 3006425876-2025-00370, AND 3006425876-2025-00369.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21838472 ↗
• MalfunctionApr 15, 2025Crack; Crack

  IT WAS REPORTED "WHEN THE SYRINGE IS GENTLY PUSHED ONTO THE LUER CONNECTOR, THE PUNCTURE CANNULA CAN BECOME HAIRLINE CRACKED OR SPLINTER COMPLETELY. IN ONE CASE, THE CANNULA WAS ALREADY DEFECTIVE WHEN UNPACKED." A NEW CANNULA WAS USED SUCCESSFULLY. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN" AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00371, 3006425876-2025-00370, AND 3006425876-2025-00369.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21838465 ↗
• MalfunctionApr 15, 2025Crack; Crack

  IT WAS REPORTED "WHEN THE SYRINGE IS GENTLY PUSHED ONTO THE LUER CONNECTOR, THE PUNCTURE CANNULA CAN BECOME HAIRLINE CRACKED OR SPLINTER COMPLETELY. IN ONE CASE, THE CANNULA WAS ALREADY DEFECTIVE WHEN UNPACKED." THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00371, 3006425876-2025-00370, AND 3006425876-2025-00369.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21838459 ↗
• MalfunctionFeb 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT "THE GUIDEWIRE BECAME DEFORMED AND OPENED IN TWO PLACES. AS A RESULT, ANOTHER CATHETER HAD TO BE INSERTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401965 ↗
• MalfunctionFeb 13, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DAMAGE TO THE PRODUCT WAS DISCOVERED WHEN UNPACKING THE CENTRAL VENOUS CATHETER. A HOLE WAS FOUND IN THE EXTENSION LINE (CS-15703-E; AFFECTED BATCH NUMBER 71F22M1612) DURING INSERTION, AND ONE EXTENSION LINE (DE-15853-KWEN; AFFECTED BATCH NUMBER 71F24H1309) WAS FOUND TO BE SLIT DURING PREPARATION. A THIRD CATHETER WAS USED TO RESOLVE THE ISSUE. THE PATIENT HAD NO HARM OR INJURY. THE ASSOCIATED EMDR REPORT NUMBERS ARE 3006425876-2025-00155.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374958 ↗
• MalfunctionMay 20, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "SWG KINKED". THE ALLEGED DEFECT WAS FOUND PRIOR TO USE. NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352887 ↗
• MalfunctionMay 20, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "SWG KINKED". THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT THEREFORE NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351319 ↗
• MalfunctionApr 26, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED " THE DOCTOR FOUND THE SWG KINKED DURING USED ON THE PATIENT." THEY 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 19190661 ↗
• MalfunctionApr 26, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED " THE DOCTOR FOUND THE SWG KINKED DURING USED ON THE PATIENT." THEY CHANGED TO A NEW SET. NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS RPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19190652 ↗
• MalfunctionApr 26, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED " THE DOCTOR FOUND THE SWG KINKED DURING USED ON THE PATIENT." THEY CHANGED TO A NEW SET. NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS RPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19190644 ↗
• MalfunctionApr 26, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED " THE DOCTOR FOUND THE SWG KINKED DURING USED ON THE PATIENT." THEY 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 19190639 ↗
• MalfunctionApr 26, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED " THE DOCTOR FOUND THE SWG KINKED DURING USED ON THE PATIENT." THEY CHANGED TO A NEW SET. NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS RPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19190627 ↗
• MalfunctionApr 10, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "SWG KINKING". 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 19078149 ↗
• MalfunctionDec 27, 2023Gas/Air Leak; Gas/Air Leak

  THE REPORT STATES, "THEY FOUND THE DEFECTED INTRODUCER NEEDLE THAT CANNOT SUCK SOLUTION AND CAUSE AIR EMBOLISM INTO SYRINGE WHEN THEY INSERT THE NEEDLE TO THE PATIENT VESSEL. THE PROBLEM SOLVED BY CHANGE THE NEW CVC SET". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18402357 ↗
• MalfunctionAug 7, 2023Stretched; Stretched

  IT WAS REPORTED "UPON GOING TO THE ROOM FOR ROUTINE CHECK-UPS, NURSING STAFF NOTICED THAT THE MEDIAL LUMEN OF THE CENTRAL VENOUS CATHETER HAD A SOFTENED APPEARANCE". THE CATHETER WAS PLACED ON 29JUN2023 IN THE RIGHT FEMORAL. THE CATHETER WAS NOT REMOVED OR REPLACED. THE PHYSICIAN DECIDED TO CLOSE THE LUMEN AND USE ONLY THE TWO REMAINING LUMENS. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17476567 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K862056. One submission often covers many models, so check the product and lot details in each record.

• Z-2377-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSE
• Z-1118-2019 · Jan 10, 2019 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
• Z-1119-2019 · Jan 10, 2019 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter Product Code: CD-10802 GTN: 00801902015396
• Z-0723-2019 · Nov 14, 2018 · Terminated
  Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide sho
• Z-2818-2018 · Jul 10, 2018 · Terminated
  HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous cathe
• Z-2819-2018 · Jul 10, 2018 · Terminated
  HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous cath
• Z-2336-2018 · May 11, 2018 · Terminated
  Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single
• Z-1982-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters; Product Code: ASK-21142-WHC2
• Z-1967-2018 · Apr 11, 2018 · Terminated
  Maximal Barrier Drape; Product Code: ASK-04000-HMC
• Z-1978-2018 · Apr 11, 2018 · Terminated
  Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP
• Z-1332-2018 · Dec 22, 2017 · Terminated
  (1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12
• Z-0652-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features; Product Code: ASK-12703-WMC1; Exp. Dat
• Z-0648-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; Exp. Dates Feb 2018 - Nov 2018
• Z-0657-2018 · Oct 17, 2017 · Terminated
  Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
• Z-0654-2018 · Oct 17, 2017 · Terminated
  Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018

…and 9 more.