ARROW IPN920484Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902195224), received between Mar 25, 2023 and Mar 25, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (1 report).

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

3 other recalls cover devices cleared under the same FDA submission (K111117); 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 10, 2026Open, Classified

   16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

   Z-2159-2026 · 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.

• MalfunctionMar 25, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED: "AFTER THE DEVICE PLACEMENT UNDER FLUOROSCOPY, WHILE TESTING THE TWO ENDS OF THE CATHETER, THE ONE (BLUE) WAS WORKING PERFECT WHILE AT THE OTHER TIP (RED), ONE COULD WITH EXTREMELY HIGH PRESSURE ONLY INSERT SALINE." CUSTOMER REPORTED ONLY THE RED EXTENSION LINE WAS NOT WORKING PROPERLY AFTER PLACEMENT. THE DEVICE WAS REMOVED AND "THERE IS A BIG AMOUNT OF CLOT BLOCKING THE ONE OF THE TWO END HOLES". ANOTHER DEVICE WAS PLACED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616621 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111117. One submission often covers many models, so check the product and lot details in each record.

• Z-2158-2026 · Apr 10, 2026 · Open, Classified
  Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP; Cannon II Plus Hemodialysis Catheter w
• Z-2156-2026 · Apr 10, 2026 · Open, Classified
  Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
• Z-1007-2015 · Feb 4, 2013 · Terminated
  The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX