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ARROW IPN055271Recalls & reported problems

Teleflex Incorporated · NextStep(R) Antegrade Hemodialysis Catheterization Set Long-Term Access. Catheter Length, Tip to Cuff: 27 cm · Class 2 · Implant

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 20801902156017), received between Jul 21, 2021 and Jul 21, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K111900); 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.

Most reported problems

Device problems

  • Fluid/Blood Leak1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionJul 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE COMPLAINT IS REPORTED AS: THERE WERE CLINICAL SIGNS OF INFUSION (LEAKS) UNDER THE SKIN AT THE LEVEL OF THE CATHETER AFTER INSERTION. THE ISSUE WAS SOLVED BY APPLYING COMPRESSION BECAUSE OF SUSPICION OF OEDEMA AND POST-INSERTION HEMATOMA. NEVERTHELESS SYMPTOMS RESUMED 10 DAYS LATER WHEN THE COMPRESSION WAS STOPPED. THE DEVICE WAS CHANGED. IT WAS REPORTED THERE WAS NO CONSEQUENCE FOR THE PATIENT AFTER THE DEVICE WAS CHANGED.

    Patient problems: Insufficient Information

    MAUDE report 12206290 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111900. One submission often covers many models, so check the product and lot details in each record.

  • 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-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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.