ARROW IPN030354Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801902102898), received between Oct 4, 2023 and Feb 10, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (4 reports).

64 other recalls cover devices cleared under the same FDA submission (K002507); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Material Deformation

  IT WAS REPORTED THAT: "THE ISSUE APPEARS TO BE THAT THE CATHETER WAS DEFORMED (FLATTENED. PATIENT IS FINE. REPLACED WITH A NEW ONE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301908 ↗
• MalfunctionFeb 9, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT "SWG DEFORMED". ADDITIONAL INFORMATION RECEIVED CLARIFIED "THE ISSUE APPEARS TO BE THAT THE CATHETER WAS DEFORMED (FLATTENED) RATHER THAN SWG." 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 24294636 ↗
• MalfunctionJan 9, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT "OUTER TRANSPARENT PACKAGE DAMAGED. UPON OPENING, A DAMAGED CORNER WAS FOUND; THEREFORE, THE DEVICE WAS NOT USED TO AVOID CONTAMINATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24018400 ↗
• MalfunctionOct 2, 2025Crack; Crack

  IT WAS REPORTED THAT "AN INCIDENT OCCURRED ON (B)(6) 2025 IN OUR HOSPITAL'S POST ANESTHESIA CARE UNIT. WHILE INSERTING A CATHETER IN THE EMERGENCY ROOM IN RESPONSE TO HAEMORRHAGIC SHOCK, A PROBLEM WAS ENCOUNTERED WITH THE PUNCTURE NEEDLE. IT APPEARED TO BE MULTI-PERFORATED, MAKING IT IMPOSSIBLE TO DRAW BLOOD. A SECOND OPERATOR TOOK OVER AND CHANGED THE SYRINGE, BUT WITH THE SAME RESULT. A THIRD OPERATOR TOOK OVER AND CHANGED THE NEEDLE, WHICH PROVED SUCCESSFUL: THEY WERE ABLE TO DRAW BLOOD AND INSERT THE CATHETER." THERE WAS A DELAY FOR THE MASSIVE TRANSFUSION. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DECEASED". ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00903 AND 3006425876-2025-00904.

  Patient problems: Insufficient Information

  MAUDE report 23199881 ↗
• MalfunctionOct 2, 2025Crack; Crack

  IT WAS REPORTED THAT " AN INCIDENT OCCURRED ON (B)(6) 2025 IN OUR HOSPITAL'S POST ANESTHESIA CARE UNIT. WHILE INSERTING A CATHETER IN THE EMERGENCY ROOM IN RESPONSE TO HAEMORRHAGIC SHOCK, A PROBLEM WAS ENCOUNTERED WITH THE PUNCTURE NEEDLE. IT APPEARED TO BE MULTI-PERFORATED, MAKING IT IMPOSSIBLE TO DRAW BLOOD. A SECOND OPERATOR TOOK OVER AND CHANGED THE SYRINGE, BUT WITH THE SAME RESULT. A THIRD OPERATOR TOOK OVER AND CHANGED THE NEEDLE, WHICH PROVED SUCCESSFUL: THEY WERE ABLE TO DRAW BLOOD AND INSERT THE CATHETER. "THERE WAS A DELAY FOR THE MASSIVE TRANSFUSION. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DECEASED". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00903 AND 3006425876-2025-00904.

  Patient problems: Insufficient Information

  MAUDE report 23199789 ↗
• MalfunctionApr 15, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND A GUIDE WIRE BEND. SO THE MD OPENED UP THE NEW KIT TO FINISH 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 21838742 ↗
• MalfunctionDec 16, 2024Material Deformation; Material Deformation

  IT WAS REPORTED: 'DURING THE PROCEDURE, IN ACCORDANCE WITH THE IFU, THE PHYSICIAN FOUND A GUIDE WIRE BROKEN'. A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20937386 ↗
• MalfunctionJul 23, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND GUIDE WIRE DEFECT (WIRE BENDING PHENOMENON OCCURS). SO THE MD OPENED UP THE NEW KIT TO FINISH 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 19804567 ↗
• MalfunctionMay 1, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND THE GUIDE WIRE TO BE FAULTY. SO THE MD OPEND UP THE NEW KIT TO FINISH THE PROCEDURE. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219486 ↗
• MalfunctionFeb 26, 2024Crack; Connection Problem; Crack; Connection Problem

  IT WAS REPORTED "THE MD FOUND A LEAK IN THE PART CONNECTING THE NEEDLE SYRINGE. SO THE MD OPEND UP THE NEW KIT TO FINISH THE PROCEDURE." NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18779215 ↗
• MalfunctionFeb 8, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND THE DILATOR TO BE BENT. SO THE MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18666184 ↗
• MalfunctionJan 2, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: DURING THE PROCDEURE ACCORDING TO IFU, MD FOUND THAT GUIDE WIRE BENT AND KINKED. SO MD OPEND UP THE NEW KIT TO FINISH THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18423958 ↗
• MalfunctionDec 8, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, MD FOUND THAT GUIDE WIRE BENT. SO MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18289797 ↗
• MalfunctionDec 1, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, MD FOUND THAT WIRE BENTED. SO MD OPEND UP THE NEW KIT TO FINISH THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18245362 ↗
• MalfunctionNov 14, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT: THE DILATOR DEFORMED DURING USE. ANOTHER KIT WAS OPENED TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129867 ↗
• MalfunctionOct 4, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THE DOCTOR FOUND THE CATHETER KINKED DURING USE ON THE PATIENT. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17870878 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002507. One submission often covers many models, so check the product and lot details in each record.

• Z-2385-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH;
• Z-0352-2023 · Oct 27, 2022 · Terminated
  Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-
• Z-0351-2023 · Oct 27, 2022 · Terminated
  Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
• Z-1323-2018 · Dec 22, 2017 · Terminated
  (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow MAC" Two- Lumen Central Venous Access Kit, Product Number:
• Z-2335-2017 · May 9, 2017 · Terminated
  Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central ci
• Z-2261-2017 · Mar 20, 2017 · Terminated
  Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostatis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5-8 Fr
• Z-2307-2017 · Mar 20, 2017 · Terminated
  ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access
• Z-2264-2017 · Mar 20, 2017 · Terminated
  ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the
• Z-2262-2017 · Mar 20, 2017 · Terminated
  Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure injectable P1CC with chlorag+ard Antimicrobial and Antithrombogenic Technology is
• Z-2286-2017 · Mar 20, 2017 · Terminated
  Arrow PICC with Chlorag+ard Technology The ArrowEVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or lon
• Z-2284-2017 · Mar 20, 2017 · Terminated
  Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurate
• Z-2301-2017 · Mar 20, 2017 · Terminated
  QuickFlash(R) Radial Artery/Arterial Line Catheterization Kit The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vess
• Z-2289-2017 · Mar 20, 2017 · Terminated
  Arrow Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The Arrow GlideThru" Peel-Away Sheath/Dilator Introducer is used
• Z-2269-2017 · Mar 20, 2017 · Terminated
  Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intra
• Z-2273-2017 · Mar 20, 2017 · Terminated
  Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions The

…and 49 more.