Skip to content

ARROW IPN033042Recalls & reported problems

Teleflex Incorporated · Edge(R) Hemodialysis Catherization Set Long-Term Access. Catheter Length, Cuff to Tip; 23 cm · Class 2 · Implant

All models of ARROW (1494)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801902096364), received between Sep 29, 2023 and Sep 29, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Material Deformation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionSep 29, 2023Material Deformation; Material Deformation

    IT WAS REPORTED "TIP OF CATHETER IS DAMAGED" DURING USE. NO PATIENT HARM WAS REPORTED. A NEW CATHETER WAS USED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17842320 ↗

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-2156-2026 · Apr 10, 2026 · Open, Classified
    Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
  • Z-2159-2026 · Apr 10, 2026 · Open, Classified
    NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep A
  • 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-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

Other Catheter, hemodialysis, implanted devices

All Catheter, hemodialysis, implanted devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page