ARROW IPN033803Recalls & reported problems
Teleflex Incorporated · OnControl® Bone Lesion Biopsy System Tray 10ga 10cm / 12ga 14cm · Class 2
All models of ARROW (1494)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10816000012366), received between Mar 18, 2024 and Mar 18, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (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.
Reports received per month
Most reported problems
Device problems
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2024Material Separation; Material Separation
IT WAS REPORTED THAT: "OSTEOID OSTEOMA IN THE FEMUR. WENT IN WITH GREEN INTRODUCER. FOLLOWED WITH ORANGE NEEDLE. WAS TAKING 1/2 CM SAMPLES. WAS ADVANCING NEEDLE AND THEN ORANGE HUB SNAPPED OFF. PHYSICIAN WAS ABLE TO REMOVE GREEN INTRODUCER AND THEN HAD ORTHO COME IN TO HELP REMOVE REMAINING NEEDLE. ABOUT 1 CM OF DISTAL BIOPSY NEEDLE WAS LEFT BEHIND IN THE BONE. THE TIP OF THE BIOPSY NEEDLE IS IN THE PATIENTS BONE. THE PATIENT IS FINE.
Patient problems: Foreign Body In Patient
MAUDE report 18920214 ↗
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, ClassifiedArrow 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 · TerminatedARROW 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.
Other INSTRUMENT, BIOPSY devices
- MAX-CORE MC1616Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall4,258 reports
- ENCOR® ECP017GSenorx, Inc. · INSTRUMENT, BIOPSY1 recall4,186 reports
- MAX-CORE MC1820Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall2,404 reports
- MAX-CORE MC1816Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall1 death848 reports
- MAX-CORE MC1410Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall399 reports
- MAX-CORE MC1610Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall394 reports
- ENCOR® ECP0110GVSenorx, Inc. · INSTRUMENT, BIOPSY392 reports
- ENCOR® ECP0110GSenorx, Inc. · INSTRUMENT, BIOPSY390 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page