ARROW IPN923012Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10801902205428), received between Jul 13, 2023 and Jul 1, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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

1 other recall cover devices cleared under the same FDA submission (K963257); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "THE PEEL AWAY WINGS BROKE OFF DURING INSERTION MAKING IT VERY DIFFICULT TO GRIP THE REMAINING PART OF PEEL AWAY SHEATH AND REMOVE. COMPLETED THE PROCEDURE WITH THIS DIFFICULTY. NO ADVERSE EFFECTS TO PATIENT OR MIDLINE PERFORMANCE." ASSOCIATED COMPLAINTS 9680794-2024-00639 AND 9680794-2024-00638.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19642799 ↗
• MalfunctionMay 24, 2024Material Deformation; Difficult or Delayed Separation; Material Deformation; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE "SHEATH BROKE DURING INSERTION AND THEY HAD TO OPEN A STANDALONE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391004 ↗
• MalfunctionDec 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: THE MIDLINE WAS BEING USED IN THE HOSPITAL FOR ONE DAY WHEN IT STARTED LEAKING. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18333753 ↗
• MalfunctionDec 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: THE HANDLE OF THE PEEL AWAY SHEATH BROKE OFF. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED. ASSOCIATED TO 9680794-2023-00929.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18273125 ↗
• MalfunctionJul 13, 2023Material Deformation; Material Deformation

  CUSTOMER REPORTED KINKING OF INTRODUCER/GLIDE THRU SHEATH. NO PATIENT HARM WAS REPORTED. A NEW SHEATH WAS USED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321676 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963257. One submission often covers many models, so check the product and lot details in each record.

• Z-2385-2018 · May 17, 2018 · Terminated
  Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utiliz