ARROW IPN033806Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10816000012380), received between Jan 10, 2022 and Apr 30, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Separation” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT: "A PIECE OF THE NEEDLE BROKE OFF IN A PATIENT." ADDITIONAL INFORMATION: "THE PROCEDURE WAS A BONE LESION BIOPSY OF THE RIGHT ILIAC CREST. WE RECEIVED NEW BIOPSY GUNS WITHIN THE LAST 6-8 MONTHS. A PIECE OF NEEDLE BROKE OFF IN PATIENT'S RIGHT ILIAC CREST. REMOVED REMAINING PRODUCT FROM PATIENT, REPORTED INCIDENT TO HOSPITAL AND CONTACTED VENDOR." THE PATIENT WAS REPORTED AS FINE/STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19215149 ↗
• InjurySep 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: THE ACCESS NEEDLE BROKE IN THE PATIENT'S PELVIS DURING THE BIOPSY AND HAD TO BE REMOVED SURGICALLY. THE PROCEDURE WAS SUCCESSFUL, AND THE ENTIRETY OF THE NEEDLE WAS RECOVERED. THE PATIENT IS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17823857 ↗
• InjuryJan 10, 2022Positioning Failure; Positioning Failure

  AS REPORTED: THE USER APPROACHED THE BONE TUMOR TISSUE WITH THE ON CONTROL ACCESS NEEDLE. HOWEVER, THE NEEDLE ROTATION WAS SLOW ON CT, AND THE PUNCTURE DID NOT PROCEED. THEN, THE NEEDLE BEGAN TO HEAT UP SO THAT THE USER STOPPED USING IT. THE USER CHANGED TO A MANUAL BIOPSY AND CONTINUED THE APPROACH, BUT AS A RESULT, THE PROCEDURE ITSELF WAS COMPLETED. LATER, WHEN THE USER VERIFIED THE CT IMAGE, IT WAS FOUND THAT THE TIP OF THE NEEDLE WAS DULL. THEREFORE, THE USER WAS WORRIED THAT THE TIP OF THE NEEDLE MIGHT HAVE COME OFF DURING THE OPERATION AND THAT THERE WERE NO REMNANTS IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED 20DEC2021: BY RECONFIRMING CT FLUOROSCOPY IMAGE BY THE USER, IT WAS FOUND THAT NO FRAGMENT WAS LEFT IN THE PATIENT, AND THE NEEDLE TIP WAS NOT WORN. THE OSTEOSCLEROTIC LESION WAS TOO HARD FOR THE ACCESS NEEDLE TO REACH NEAR THE LESION. FROM THE IMAGE FINDINGS, IT WAS FOUND THAT THE ROTATION OF THE DRIVER WAS NOT SUFFICIENTLY TRANSMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13204460 ↗

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.