ARROW IPN038089Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10801902136579), received between Sep 25, 2024 and Jan 6, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT " AROUND DAY 3 OR 4 AFTER A SUCCESSFUL INSERTION, THE MIDLINE STARTS LEAKING AT THE INSERTION SITE WHEN SALINE/FLUIDS ARE BEING PUSHED THROUGH. THIS IS HAPPENING WITH 4 IN PATIENT AND 1 OUTPATIENT. THE LINE IS REMOVED WHEN THIS ISSUE HAPPENS. THE VAT HAD THE OPPORTUNITY TO PUSH SALINE THROUGH THE REMOVED MIDLINE AND THEY NOTICED THAT THE SALINE WAS COMING OUT THE DISTAL END OF THE MIDLINE ON AN ANGLE, ALMOST OUT TO THE SIDE. IT'S A SINGLE LUMEN SO NO SIDE SKIVES. THEY WERE USING FOR HYDRATION X 2 PATIENTS AND ANTIBIOTICS FOR OTHERS." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2026-00037, 9680794-2026-00038, 9680794-2026-00039, 9680794-2026-00040.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973814 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT " AROUND DAY 3 OR 4 AFTER A SUCCESSFUL INSERTION, THE MIDLINE STARTS LEAKING AT THE INSERTION SITE WHEN SALINE/FLUIDS ARE BEING PUSHED THROUGH. THIS IS HAPPENING WITH 4 IN PATIENT AND 1 OUTPATIENT. THE LINE IS REMOVED WHEN THIS ISSUE HAPPENS. THE VAT HAD THE OPPORTUNITY TO PUSH SALINE THROUGH THE REMOVED MIDLINE AND THEY NOTICED THAT THE SALINE WAS COMING OUT THE DISTAL END OF THE MIDLINE ON AN ANGLE, ALMOST OUT TO THE SIDE. IT'S A SINGLE LUMEN SO NO SIDE SKIVES. THEY WERE USING FOR HYDRATION X 2 PATIENTS AND ANTIBIOTICS FOR OTHERS." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2026-00037, 9680794-2026-00038, 9680794-2026-00039, AND 9680794-2026-00041.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973799 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT " AROUND DAY 3 OR 4 AFTER A SUCCESSFUL INSERTION, THE MIDLINE STARTS LEAKING AT THE INSERTION SITE WHEN SALINE/FLUIDS ARE BEING PUSHED THROUGH. THIS IS HAPPENING WITH 4 IN PATIENT AND 1 OUTPATIENT. THE LINE IS REMOVED WHEN THIS ISSUE HAPPENS. THE VAT HAD THE OPPORTUNITY TO PUSH SALINE THROUGH THE REMOVED MIDLINE AND THEY NOTICED THAT THE SALINE WAS COMING OUT THE DISTAL END OF THE MIDLINE ON AN ANGLE, ALMOST OUT TO THE SIDE. IT'S A SINGLE LUMEN SO NO SIDE SKIVES. THEY WERE USING FOR HYDRATION X 2 PATIENTS AND ANTIBIOTICS FOR OTHERS." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2026-00037, 9680794-2026-00038, 9680794-2026-00040, AND 9680794-2026-00041.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973780 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT " AROUND DAY 3 OR 4 AFTER A SUCCESSFUL INSERTION, THE MIDLINE STARTS LEAKING AT THE INSERTION SITE WHEN SALINE/FLUIDS ARE BEING PUSHED THROUGH. THIS IS HAPPENING WITH 4 IN PATIENT AND 1 OUTPATIENT. THE LINE IS REMOVED WHEN THIS ISSUE HAPPENS. THE VAT HAD THE OPPORTUNITY TO PUSH SALINE THROUGH THE REMOVED MIDLINE AND THEY NOTICED THAT THE SALINE WAS COMING OUT THE DISTAL END OF THE MIDLINE ON AN ANGLE, ALMOST OUT TO THE SIDE. IT'S A SINGLE LUMEN SO NO SIDE SKIVES. THEY WERE USING FOR HYDRATION X 2 PATIENTS AND ANTIBIOTICS FOR OTHERS." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2026-00037, 9680794-2026-00039, 9680794-2026-00040, AND 9680794-2026-00041

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973735 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT " AROUND DAY 3 OR 4 AFTER A SUCCESSFUL INSERTION, THE MIDLINE STARTS LEAKING AT THE INSERTION SITE WHEN SALINE/FLUIDS ARE BEING PUSHED THROUGH. THIS IS HAPPENING WITH 4 IN PATIENT AND 1 OUT PATIENT. THE LINE IS REMOVED WHEN THIS ISSUE HAPPENS. THE VAT HAD THE OPPORTUNITY TO PUSH SALINE THROUGH THE REMOVED MIDLINE AND THEY NOTICED THAT THE SALINE WAS COMING OUT THE DISTAL END OF THE MIDLINE ON AN ANGLE, ALMOST OUT TO THE SIDE. IT'S A SINGLE LUMEN SO NO SIDE SKIVES. THEY WERE USING FOR HYDRATION X 2 PATIENTS AND ANTIBIOTICS FOR OTHERS." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2026-00037, 9680794-2026-00038, 9680794-2026-00039, 9680794-2026-00040, AND 9680794-2026-00041

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973665 ↗
• MalfunctionOct 7, 2024Crack; Separation Problem; Crack; Separation Problem

  IT WAS REPORTED "DILATOR CRACKED IN THE MIDDLE OF SHEATH WHILE PULLING SHEATH AWAY FROM CATHETER." ADDITIONAL INFORMATION CLARIFIES "THE PEEL AWAY SHEATH TEARS INCORRECTLY." 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 20382553 ↗
• MalfunctionSep 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: " MIDLINE CATHETER INSERTION IS PERFORMED WITHOUT COMPLICATIONS, A SINGLE PUNCTURE, AND AFTER 1 HOUR A LEAK OCCURS THROUGH THE PROXIMAL LUMEN (WHITE). IRRIGATION IS PERFORMED WITH A 10 ML PREFILLED SYRINGE ON SEVERAL OCCASIONS AND A LEAK IS OBSERVED WHEN IRRIGATING THE CATHETER. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20299265 ↗
• MalfunctionSep 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: "MIDLINE CATHETER INSERTION IS PERFORMED WITHOUT COMPLICATIONS, A SINGLE PUNCTURE, AND AFTER 1 HOUR, LEAKAGE OCCURS THROUGH THE PROXIMAL LUMEN (WHITE). THIS IS ASSOCIATED WITH THE LENGTH OF THE DEVICE, SINCE IT IS 15 CM AND ITS TIP DOES NOT REMAIN IN THE SUBCLAVIAN VEIN. IRRIGATION IS PERFORMED WITH A 10 ML PREFILLED SYRINGE ON SEVERAL OCCASIONS AND LEAKAGE IS OBSERVED WHEN IRRIGATING THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20299037 ↗

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