ARROW IPN038090Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801902136586), received between Oct 27, 2023 and Dec 3, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K161313); 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.

• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "THE PATIENT HAS BEEN CARRYING A MIDLINE CATHETER SINCE (B)(6) 2025. ON (B)(6) 2025, A CALL WAS RECEIVED FROM THE NURSING ASSISTANT STAFF. UPON EVALUATING THE DEVICE, IT WAS CONFIRMED THAT THE CATHETER WAS PROPERLY STABILIZED WITH A TRANSPARENT DRESSING AND SHOWED NO DISPLACEMENT. HOWEVER, LEAKAGE WAS OBSERVED AT THE INSERTION SITE DURING IRRIGATION OF THE WHITE LUMEN, AND THERE WAS NO BLOOD RETURN THROUGH THE CATHETER. "PDP." REPORTED THAT THE GUIDEWIRE WAS BENT AND PRESENTED RESISTANCE WHEN ATTEMPTING TO ADVANCE IT; ANOTHER IDENTICAL UNIT WAS USED." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATE MDR NUMBERS INCLUDE: 9680794-2025-01006 AND 9680794-2025-01043.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704976 ↗
• MalfunctionDec 3, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE PATIENT HAS BEEN CARRYING A MIDLINE CATHETER SINCE (B)(6) 2025. ON (B)(6) 2025, A CALL WAS RECEIVED FROM THE NURSING ASSISTANT STAFF. UPON EVALUATING THE DEVICE, IT WAS CONFIRMED THAT THE CATHETER WAS PROPERLY STABILIZED WITH A TRANSPARENT DRESSING AND SHOWED NO DISPLACEMENT. HOWEVER, LEAKAGE WAS OBSERVED AT THE INSERTION SITE DURING IRRIGATION OF THE WHITE LUMEN, AND THERE WAS NO BLOOD RETURN THROUGH THE CATHETER. "PDP." REPORTED THAT THE GUIDEWIRE WAS BENT AND PRESENTED RESISTANCE WHEN ATTEMPTING TO ADVANCE IT; ANOTHER IDENTICAL UNIT WAS USED." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATE MDR NUMBERS INCLUDE: 9680794-2025-01006.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704959 ↗
• MalfunctionSep 25, 2024Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT: "UNCOMPLICATED MIDLINE CATHETER INSERTION IS PERFORMED. LEAKAGE IS OBSERVED WHEN THE CATHETER IS IRRIGATED. OCCURRED AT ONE END OF THE CATHETER, FRACTURE OF THE PROXIMAL REGION CAUSING A LEAK. WE FIXED THE PROBLEM BY USING ANOTHER CATHETER WITH NO QUALITY FAULTS. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20299063 ↗
• MalfunctionSep 6, 2024Material Separation; Material Separation

  IT IS REPORTED THAT: "AN ATTEMPT IS MADE TO INSERT A 5.5 FR BILUMEN MEDICAL LINE CATHETER, BUT DESPITE CUTTING THE SKIN WITH A SCALPEL THAT COMES IN THE KIT AND PERFORMING A SCREW TECHNIQUE WHEN INSERTING A DILATOR + PEELABLE, THE DEVICE MALFUNCTIONS BECAUSE THE PEELABLE WAS BROKEN , SO A CATHETER CHANGE IS REQUESTED TO COMPLETE INSERTION OF VENOUS ACCESS." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157108 ↗
• MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: THE CATHETER AT THE INSERTION POINT LEAKS INTRAVENOUS FLUIDS. ADDITIONAL INFORMATION: THERE WAS REDNESS ON THE SKIN AT THE INSERTION SITE BUT THERE WAS NO OTHER HARM OR CONSEQUENCE TO THE PATIENT. THERE WAS NO MEDICAL INTERVENTION NEEDED. THE CATHETER WAS REMOVED.

  Patient problems: Inflammation

  MAUDE report 18719671 ↗
• MalfunctionOct 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: WHEN ATTEMPTING TO SEPARATE THE SHEATH USING THE PLASTIC TABS AT THE TOP OF THE SHEATH THE TWO HALVES DID NOT SEPARATE. ONE OF THE PLASTIC TABS BROKE AND A STERILE FORCEPS WAS NEEDED TO SEPARATE THE SHEATH. THIS WAS SUCCESSFUL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18020690 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161313. One submission often covers many models, so check the product and lot details in each record.

• Z-0102-2023 · Sep 14, 2022 · Terminated
  ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intrave
• Z-1818-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS