ARROW IPN922601Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902201970), received between Sep 27, 2023 and Sep 27, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

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

4 other recalls cover devices cleared under the same FDA submission (K103255); 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.

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-2367-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  PICC NURSE NOTICED WIRE WAS KINKED ON THE END AFTER REMOVING IT FROM THE KIT. A NEW KIT WAS USED TO PERFORM THE PROCEDURE. NO PATIENT INVOLVEMENT WITH DEVICE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17825642 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103255. One submission often covers many models, so check the product and lot details in each record.

• Z-0179-2018 · Jun 1, 2017 · Terminated
  Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately
• Z-2170-2017 · Apr 28, 2017 · Terminated
  Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
• Z-2489-2015 · Jul 30, 2015 · Terminated
  Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days
• Z-2462-2015 · Jul 30, 2015 · Terminated
  PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound