ARROW IPN038336Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902138887), received between Feb 22, 2021 and Feb 22, 2021 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K991431); 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

Recent adverse event reports

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

• MalfunctionFeb 22, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  CUSTOMER REPORTED THAT "AS THE ICU PATIENT WAS IN NEED OF DIALYSIS, AN ACUTE HAEMODIALYSIS CATHETER WAS PLACED (FEMORAL PLACEMENT). THE CATHETER GOT PLACED CORRECTLY (THE CATHETER FUNCTIONS PROPERLY) AND THE CATHETER GOT PLACED ACCORDING TO THE IFU. WHEN THE NEPHROLOGIST WITHDREW THE SWG, IT WAS NEVERTHELESS KINKED AND DISENTANGLED. " NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION WAS REPORTED AS CRITICAL, UNRELATED TO THE DEVICE. THE PATIENT REMAINED IN ICU AND RECOVERING AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11361193 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K991431. One submission often covers many models, so check the product and lot details in each record.

• Z-0639-04 · Feb 18, 2004 · Terminated
  Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions