ARROW IPN037698Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 50801902130162), received between Mar 8, 2021 and Apr 16, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 21, 2026Open, Classified

   Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

   Z-2394-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "I AM AWARE OF FOUR MIDLINES THAT HAD TO BE REMOVED- THEY WERE ALL IN FOR 5-8 DAYS BEFORE I STARTED RECEIVING COMPLAINTS. THE LEAKINESS THAT WAS REPORTED WAS A SATURATED DRESSING WHEN MEDICATIONS/FLUIDS WERE PUSHED INTO THE LINE, CAUSING THEM TO LEAK DOWN THE ARM." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00321, 9680794-2025-00322, 9680794-2025-00323, 9680794-2025-00324.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21848157 ↗
• MalfunctionApr 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "I AM AWARE OF FOUR MIDLINES THAT HAD TO BE REMOVED- THEY WERE ALL IN FOR 5-8 DAYS BEFORE I STARTED RECEIVING COMPLAINTS. THE LEAKINESS THAT WAS REPORTED WAS A SATURATED DRESSING WHEN MEDICATIONS/FLUIDS WERE PUSHED INTO THE LINE, CAUSING THEM TO LEAK DOWN THE ARM." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00321, 9680794-2025-00322, 9680794-2025-00323, 9680794-2025-00324

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21848142 ↗
• MalfunctionApr 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "I AM AWARE OF FOUR MIDLINES THAT HAD TO BE REMOVED- THEY WERE ALL IN FOR 5-8 DAYS BEFORE I STARTED RECEIVING COMPLAINTS. THE LEAKINESS THAT WAS REPORTED WAS A SATURATED DRESSING WHEN MEDICATIONS/FLUIDS WERE PUSHED INTO THE LINE, CAUSING THEM TO LEAK DOWN THE ARM." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00321, 9680794-2025-00323, 9680794-2025-00324.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21848119 ↗
• MalfunctionApr 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "I AM AWARE OF FOUR MIDLINES THAT HAD TO BE REMOVED- THEY WERE ALL IN FOR 5-8 DAYS BEFORE I STARTED RECEIVING COMPLAINTS. THE LEAKINESS THAT WAS REPORTED WAS A SATURATED DRESSING WHEN MEDICATIONS/FLUIDS WERE PUSHED INTO THE LINE, CAUSING THEM TO LEAK DOWN THE ARM." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00321, 9680794-2025-00322, 9680794-2025-00323, 9680794-2025-00324.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21848097 ↗
• MalfunctionFeb 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "THE PRODUCT IS LEAKING AROUND THE INSERTION SIDE. THE PATIENT HAD TO RECEIVE ANOTHER LINE. THE MEDICATIONS HAD TO BE GIVEN THROUGH A PERIPHERAL LINE". THE PATIENT IS STABLE, AND THE INCIDENT CAUSED NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356133 ↗
• MalfunctionAug 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THE MIDLINE CATHETER WAS PLACED BY THE USER FACILITY ON (B)(6) 2022. THE PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY AND RETURNED TO THE HOSPITAL ON (B)(6) 2022 BECAUSE THE WHITE HUB HAD FALLEN OFF IN THE SKILLED NURSING FACILITY. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15224771 ↗
• MalfunctionMar 14, 2022Material Deformation; Material Deformation

  THE INSERTING NURSE BELIEVED THE GAP/SPACING BETWEEN THE DILATOR AND SHEATH WAS LARGER THAN NORMAL MAKING IT DIFFICULT TO ADVANCE THE SHEATH THROUGH THE PATIENT'S SKIN. THIS CAUSED THE SHEATH TO "FRAY AND PEEL BACK ON ITSELF". THE NURSE WAS ABLE TO ADVANCE AND INSERT THE CATHETER WITHOUT HAVING MUCH OF THE SHEATH IN THE VEIN. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13762807 ↗
• MalfunctionApr 23, 2021Break; Break

  THE COMPLAINT IS REPORTED AS: WHEN BREAKING THE SHEATH, ONE SIDE ARM DETACHED FROM THE SHEATH. THE NURSE WAS ABLE TO CONTINUE TO PEEL THE SHEATH WITHOUT THE SIDE ARM. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11719421 ↗
• MalfunctionMar 8, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE NURSE HAD DIFFICULTY THREADING THE CATHETER THROUGH THE SHEATH. THE SHEATH AND DILATOR WERE INSERTED IN THE VESSEL. THE DILATOR WAS REMOVED AND THE CATHETER WOULD NOT GO THROUGH THE SHEATH. THE NURSE WAS UNABLE TO FINISH INSERTION. A TRIALYSIS CATHETER WAS PLACED THE NEXT DAY. NO PATIENT INJURY OR COMPLICATION REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11439273 ↗

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