ARROW IPN032907Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10801902024418), received between Jun 26, 2023 and Nov 12, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: "TEST OF THE BROWN MAC LINE FOR BLOOD DRAW VIA THE BROWN LUMEN: PRESENCE OF A YELLOWISH/BEIGE CLOT IN THE LUMEN. THE BROWN LINE WAS CLOSED ACCORDING TO PROTOCOL WITH A PULSED FLUSH OF 20 ML OF 0.9% NACL AND A 3 ML HEPARIN LOCK ON (B)(6) AT 6:00 AM. THE DISTAL LINE REMAINED OPEN WITH A CONTINUOUS INFUSION OF 10 ML OF 0.9% NACL UNTIL THE THROMBOTIC OCCLUSION CLOT WAS OBSERVED IN THE BROWN LUMEN. CATHETER REMOVAL REVEALED THE PRESENCE OF THE CLOT IN BOTH THE PROXIMAL AND DISTAL LUMENS. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE WITH NO HARM OR CONSEQUENCES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23530735 ↗
• MalfunctionNov 5, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "UPON REMOVAL OF THE MAC CATHETER, A CLOT WAS OBSERVED IN THE DISTAL/INTRODUCTORY LUMEN. PATIENT IS ON DAY 5. 0.9% NACL IS CURRENTLY INFUSING THROUGH THE PROXIMAL LINE AT 10 CC/HR." THE DEVICE WAS REMOVED. 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 23476598 ↗
• MalfunctionNov 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT "CLOT EXTRACTED VIA THE MAC CATHETER FROM THE DISTAL LINE DESPITE CONTINUOUS IRRIGATION WITH NACL AT 3 CC/HR UNDER 300 PSI PRESSURE FOR CVP MONITORING, AND THE PRESENCE OF NACL AT 10 CC/HR IN THE DISTAL LINE. CLOT EXTRACTION PERFORMED ON DAY 2 POST-INSERTION ". THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23451648 ↗
• MalfunctionNov 27, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "THE INTEGRITY OF THE DILATOR WAS COMPROMISED." THE TIP OF THE DILATOR WAS DAMAGED DURING INSERTION INTO THE PATIENT. THE USER CHANGED TO A NEW SET. 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 20797567 ↗
• InjuryJun 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  CUSTOMER REPORTS CONCERN WITH CLEAR LABELING OF OUTER DIMENSION OF THE MAC PROXIMAL LINE ON PACKAGING. IT WAS REPORTED "THEY BELIEVE THE 9F ON THE PACKAGING IS MISLEADING AS THEY THINK THE PROXIMAL IS A LOT LARGER". CUSTOMER REPORTS "PATIENT HAD A POTENTIAL S.I. (SERIOUS INCIDENT) DUE TO THE LARGE WOUND BEING LEFT AND IS NOW GOING TO BE ON LIFE-LONG ANTI-PLATELETS". IT WAS REPORTED THIS MAY HAVE BEEN DUE TO INADVERTENT CANNULATION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17199880 ↗

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-2291-2017 · Mar 20, 2017 · Terminated
  Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central circulation through a peripheral vein. The intended use of the VP'S Stylet and Console (VPS Syste
• 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-2253-2017 · Mar 20, 2017 · Terminated
  MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.
• Z-2305-2017 · Mar 20, 2017 · Terminated
  ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of disease
• Z-2257-2017 · Mar 20, 2017 · Terminated
  Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally inserted Central Venous Catheter The Arrow(r) CVC is indicated to provide short-term (<30 days
• 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-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-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-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-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

…and 49 more.