ARROW IPN036421Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 60801902123420), received between Jul 10, 2023 and Sep 21, 2026 — classified as 5 malfunctions.

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

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

4 other recalls cover devices cleared under the same FDA submission (K930129); 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-2370-2026 · Root cause: Nonconforming Material/Component · 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.

• MalfunctionSep 21, 2026Stretched; Insufficient Device Problem Information

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843189 ↗
• MalfunctionSep 11, 2026Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50731754 ↗
• MalfunctionJul 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS THAT THE CATHETER IS LEAKING AT THE HUB WHERE THE EXTENSION TUBING MEETS THE HUB. THE CATHETER WAS REPLACED. THE PATIENT'S CONDITION IS REPORTED TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288479 ↗
• MalfunctionJul 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS THAT THE CATHETER IS LEAKING AT THE HUB WHERE THE EXTENSION TUBING MEETS THE HUB. THE CATHETER WAS REPLACED. THE PATIENT'S CONDITION IS REPORTED TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288451 ↗
• MalfunctionJul 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS THAT THE CATHETER IS LEAKING AT THE HUB WHERE THE EXTENSION TUBING MEETS THE HUB. THE CATHETER WAS REPLACED. THE PATIENT'S CONDITION IS REPORTED TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288443 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K930129. One submission often covers many models, so check the product and lot details in each record.

• Z-2021-2018 · Apr 11, 2018 · Terminated
  Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052
• Z-1228-2017 · Jan 11, 2017 · Terminated
  Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and
• Z-0551-05 · Sep 21, 2004 · Terminated
  Arrow PICC Kit with Blue Flex Tip Catheter and Placement Wire. Catalog number PK-01552-WSSP
• Z-0552-05 · Sep 21, 2004 · Terminated
  Arrow PICC Two Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip Catheter, Seldinger Technique with 130 cm Platinum Tipped Marked Wire. Catalog number PR-05052-LW