ONCONTROL IPN919023Recalls & reported problems
Teleflex Incorporated · OnControl® Bone Lesion Biopsy System Tray 11ga 15cm / 13ga 19cm (6/BX) · Class 2
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 10841156108540), received between Sep 5, 2024 and Sep 5, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (1 report).
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.
InjurySep 5, 2024Material Separation; Material Separation
IT WAS REPORTED THAT " PATIENT'S LESION WAS ON 9TH RIB. DR (B)(6) WAS USING ONCONTROL TO GET THE SAMPLES. DURING THE PROCEDURE, HE MADE TOTAL OF 4 ATTEMPTS TO GET THE SAMPLES WITH ONCONTROL. THE NEEDLE IS OUT FROM PATIENT'S BODY AFTER THE PROCEDURE. THEY DID A CT SCAN AND FOUND OUT THE ACCESS NEEDLE (ORANGE NEEDLE) WAS BROKEN AND LEFT INSIDE PATIENT'S BODY (9TH RIB). THE LENGTH OF THE NEEDLE THAT LEFT IN THE BODY IS ESTIMATED 0.5CM. THE NEEDLE TIP IS STILL IN THE PATIENTS BODY. THERE IS NO PLAN AT PRESENT TO REMOVE IT. THERE IS NO REPORTED HEALTH CONSEQUENCE FROM THE NEEDLE TIP."
Patient problems: Foreign Body In Patient
MAUDE report 20143702 ↗
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