ARROW IPN923911Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801902207095), received between Apr 20, 2026 and May 4, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "DURING THE PROCEDURE, THE PHYSICIAN FOUND THE CATHETER BODY WAS COMPRESSED." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. NO MEDICAL INTERVENTION WAS NECESSARY, AND THE PROCEDURE WAS COMPLETED AFTER SWITCHING TO ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071475 ↗
• MalfunctionMay 4, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "DURING CVC INSERTION TO THE RIGHT SUBCLAVIAN VEIN, THE MD FOUND THE CATHETER BODY WAS COMPRESSED AND THE GUIDEWIRE DID NOT COME OUT SMOOTHLY. WHEN THE PHYSICIAN PULLED OUT THE GUIDEWIRE AND CATHETER, THE GUIDEWIRE WAS TWISTED." IT WAS LATER CONFIRMED THAT ALL THREE DEVICES WERE USED ON THE SAME PATIENT DURING THE SAME PROCEDURE. THE PHYSICIAN OPENED A 4TH KIT TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. NO MEDICAL INTERVENTION WAS NECESSARY, AND THE PHYSICIAN OPENED A 4TH KIT TO COMPLETE THE PROCEDURE. PLEASE SEE THE ASSOCIATED MDRS: 3006425876-2026-00473, 3006425876-2026-00489, & 3006425876-2026-00488.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071333 ↗
• MalfunctionMay 4, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "DURING CVC INSERTION TO THE RIGHT SUBCLAVIAN VEIN, THE MD FOUND THE CATHETER BODY WAS COMPRESSED AND THE GUIDEWIRE DID NOT COME OUT SMOOTHLY. WHEN THE PHYSICIAN PULLED OUT THE GUIDEWIRE AND CATHETER, THE GUIDEWIRE WAS TWISTED." IT WAS LATER CONFIRMED THAT ALL THREE DEVICES WERE USED ON THE SAME PATIENT DURING THE SAME PROCEDURE. THE PHYSICIAN OPENED A 4TH KIT TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. NO MEDICAL INTERVENTION WAS NECESSARY, AND THE PHYSICIAN OPENED A 4TH KIT TO COMPLETE THE PROCEDURE. PLEASE SEE THE ASSOCIATED MDRS: 3006425876-2026-00473, 3006425876-2026-00524 & 3006425876-2026-00488.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071066 ↗
• MalfunctionMay 4, 2026Material Frayed

  IT WAS REPORTED THAT "DURING CVC INSERTION TO THE RIGHT SUBCLAVIAN VEIN, THE MD FOUND THE CATHETER BODY WAS COMPRESSED AND THE GUIDEWIRE DID NOT COME OUT SMOOTHLY. WHEN THE PHYSICIAN PULLED OUT THE GUIDEWIRE AND CATHETER, THE GUIDEWIRE WAS TWISTED." IT WAS LATER CONFIRMED THAT ALL THREE DEVICES WERE USED ON THE SAME PATIENT DURING THE SAME PROCEDURE. THE PHYSICIAN OPENED A 4TH KIT TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. NO MEDICAL INTERVENTION WAS NECESSARY, AND THE PHYSICIAN OPENED A 4TH KIT TO COMPLETE THE PROCEDURE. PLEASE SEE THE ASSOCIATED MDRS: ,3006425876-2026-00489, 3006425876-2026-00524 & 3006425876-2026-00488.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070919 ↗
• MalfunctionApr 22, 2026Dull, Blunt; Difficult to Advance; Material Too Soft/Flexible

  IT WAS REPORTED THAT "AN ATTEMPT IS MADE TO INSERT A MAC HIGH-FLOW CATHETER, BUT IT DID NOT PENETRATE THE SKIN AND BENDS DUE TO THE FLEXIBLE, NON-RIGID MATERIAL, DESPITE DILATION." GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED DEVICE ISSUE AND TO ASSESS WHETHER ANY PATIENT HARM, INJURY, OR ADVERSE HEALTH CONSEQUENCES OCCURRED. A TOTAL OF THREE DOCUMENTED ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER; HOWEVER, NO RESPONSE OR ADDITIONAL INFORMATION WAS RECEIVED. AS A RESULT, FURTHER EVALUATION OF DEVICE PERFORMANCE AND PATIENT IMPACT COULD NOT BE COMPLETED BASED ON THE INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24958424 ↗
• MalfunctionApr 20, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "THE CATHETER CANNOT BE PROPERLY CONNECTED/FITTED. THE SET WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24922436 ↗

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-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-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
• 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-2303-2017 · Mar 20, 2017 · Terminated
  ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be in
• Z-2302-2017 · Mar 20, 2017 · Terminated
  Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to
• Z-2296-2017 · 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-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-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-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-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

…and 49 more.