ARROW IPN033811Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10816000012427), received between Mar 14, 2023 and Mar 14, 2023 — classified as 1 injury.

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

2 other recalls cover devices cleared under the same FDA submission (K113872); 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.

• InjuryMar 14, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT: THE ACCOUNT REPORTED A NEEDLE BREAK IN A PATIENT. ON (B)(6), THE ONCONTROL BONE LESION BIOPSY SYSTEM WAS USED FOR A BLB IN THE LEFT ILIAC BONE. THE BONE WAS SCLEROTIC. MULTIPLE BONE BIOPSY SAMPLES WERE RETRIEVED PRIOR TO HAVING APPROXIMATELY 1CM OF THE DISTAL CANNULA BROKEN OFF IN THE ILIAC BONE. ORTHOPEDICS WERE NOTIFIED, AND THE DECISION WAS MADE TO LEAVE THE PIECE OF CANNULA EMBEDDED IN THE BONE. NO FURTHER MEDICAL/SURGICAL INTERVENTION WAS PERFORMED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS FINE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16536555 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113872. One submission often covers many models, so check the product and lot details in each record.

• Z-1374-2021 · Mar 8, 2021 · Open, Classified
  Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in European Regions only) - Pr
• Z-0677-2017 · Nov 8, 2016 · Terminated
  ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.