ARROW IPN036827Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20801902121916), received between Aug 7, 2023 and Jan 22, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

63 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.

Recalls naming this device

1. Apr 21, 2026Open, Classified

   Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

   Z-2385-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2024Material Separation; Material Separation

  IT WAS REPORTED "THE PROXIMAL LUMEN ON THE INTRODUCER BROKE OFF WHEN THE RN WAS REMOVING THE DRESSING FOR A DRESSING CHANGE". PATIENT'S CURRENT CONDITION IS "UNKNOWN". 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 18558158 ↗
• MalfunctionAug 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "IV FLUIDS NOTED TO BE LEAKING OUT OF INTRODUCER". THE INTRODUCER HAD BEEN INSERTED ON (B)(6) 2023 IN THE RIGHT INTERNAL JUGULAR AND A PULMONARY ARTERY CATHETER HAD BEEN INSERTED THROUGH THE INTRODUCER. NO PATIENT HARM REPORTED. THE INTRODUCER WAS REMOVED. THE PATIENT WAS REPORTED TO BE DISCHARGED FROM HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17470636 ↗
• MalfunctionAug 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED "IV FLUIDS NOTED TO BE LEAKING OUT OF INTRODUCER." THE INTRODUCER HAD BEEN PLACED ON (B)(6) 2023 AND WAS IN USE WITH A PULMONARY ARTERY CATHETER. THE INTRODUCER WAS REMOVED ON (B)(6) 2023. A PICC LINE WAS PLACED INSTEAD. NO PATIENT HARM REPORTED. THE PATIENT WAS REPORTED TO BE DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17470625 ↗

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-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-2292-2017 · Mar 20, 2017 · Terminated
  "Pressure Injectable Jugular Axillo-Subclavian Central Catheter (JACC) Product" The CG+ Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation thr
• 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-2298-2017 · Mar 20, 2017 · Terminated
  QuickFlash Radial Artery/Arterial Line Catheterization Kit The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
• Z-2278-2017 · Mar 20, 2017 · Terminated
  AGB+ Pressure Injectable Multi-Lumen CVC Kit intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins intended to permit venou
• Z-2282-2017 · Mar 20, 2017 · Terminated
  Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System)
• Z-2268-2017 · 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-2267-2017 · Mar 20, 2017 · Terminated
  Pressure injectable Jugular Axillo-Subclavian Central CThe CG+Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central veinatheter
• Z-2277-2017 · Mar 20, 2017 · Terminated
  Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features The ARROWg+ard Blue Plus" antimi
• Z-2260-2017 · Mar 20, 2017 · Terminated
  Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions. The
• Z-2294-2017 · Mar 20, 2017 · Terminated
  Femoral Arterial Line Catheterization Kit The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
• Z-2288-2017 · Mar 20, 2017 · Terminated
  Arrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduct

…and 48 more.