ARROW IPN033784Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10816000012267), received between Dec 4, 2023 and Mar 1, 2024 — classified as 1 injury, 1 malfunction.

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

4 other recalls cover devices cleared under the same FDA submission (K142377); 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2024Break; Break

  IT WAS REPORTED THAT: "NEEDLE BROKE AND NEEDED A "REVERSE" OPTION" ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ACCOUNT.

  Patient problems: Insufficient Information

  MAUDE report 18814618 ↗
• InjuryDec 4, 2023Material Separation; Material Separation

  CUSTOMER STATED THAT WHEN THEY WERE DOING THE PROCEDURE, IN THE POSTERIOR ILIAC CREST THE CANNULA BECAME STUCK, AND THE HUB CAME OFF. THERE WAS NO REDIRECT ATTEMPTED OR EXCESSIVE PRESSURE. THEY HAD TRIED USING KELLY CLAMPS TO WIGGLE OUT THE CANNULA WITHOUT SUCCESS. THEY HAD ALSO CONTACTED ORTHO TO ASSIST THEM IN REMOVAL. DURING THE ATTEMPTED REMOVAL BY ORTHO , THE CANNULA BROKE OFF INSIDE THE PATIENT'S BONE. IT WAS REPORTED THAT THE ILIAC CREST LESION WAS VERY HARD AND ORGANIZED. PATIENT IS STABLE AND DISCHARGED, 2.5 CM OF CANNULA LEFT IN BONE, PATIENT PROCEDURE ABORTED. AT THE TIME OF DISCHARGE THERE WAS NO PLAN FOR ANOTHER MEDICAL INTERVENTION TO REMOVE THE CANNULA.

  Patient problems: Foreign Body In Patient

  MAUDE report 18254417 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142377. One submission often covers many models, so check the product and lot details in each record.

• Z-0678-2017 · Nov 8, 2016 · Terminated
  OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult a
• Z-0676-2017 · Nov 8, 2016 · Terminated
  ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest o
• Z-0679-2017 · Nov 8, 2016 · Terminated
  ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adul
• Z-0675-2017 · Nov 8, 2016 · Terminated
  ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marro