ARROW IPN029775Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30801902144486), received between Oct 16, 2024 and Oct 16, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Degraded” (1 report).

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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2024Degraded; Difficult to Remove; Degraded; Difficult to Remove

  IT WAS REPORTED "PROBLEMS WERE ENCOUNTERED WITH REMOVING THE GUIDE INSIDE THE PATIENT; ONCE IT WAS REMOVED, IT WAS FOUND TO BE PARTLY DECOMPOSED." 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 "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20459689 ↗

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-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-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-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-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-2276-2017 · Mar 20, 2017 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions T
• Z-2254-2017 · Mar 20, 2017 · Terminated
  ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permi
• Z-2306-2017 · Mar 20, 2017 · Terminated
  Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions The A
• Z-2275-2017 · Mar 20, 2017 · Terminated
  Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter The ARROWg+ard Blue Plus" antimicrobial catheter is indicate
• Z-2299-2017 · Mar 20, 2017 · Terminated
  Arterial Catheterization Kit with Maximal Barrier Precautions The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small ves
• 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-2297-2017 · Mar 20, 2017 · Terminated
  Radial Artery Catheterization Kit with Sharps Safety Features 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

…and 49 more.