ONCONTROL IPN919027Recalls & reported problems
Teleflex Incorporated · OnControl® Bone Lesion Biopsy System Tray 11ga 10cm / 13ga 14cm (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 10841156108588), received between Aug 5, 2024 and Aug 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.
InjuryAug 5, 2024Material Separation; Material Separation
IT WAS REPORTED THAT: "PT WAS HAVING A BONE LESION BIOPSY, DURING PROCEDURE SPECIMEN WAS UNABLE TO BE OBTAINED. WHEN ATTEMPTING TO ADJUST THE CANNULA WITH THE DRILL, THE CANNULA BROKE FROM THE PLASTIC HUB THAT SITS IN THE DRILL, LEAVING THE CANNULA IN THE PATIENT. THE CANNULA WAS UNABLE TO BE REMOVED WITH MANUAL TRACTION." AI RECEIVED ON 11JUL2024: PT HAD TO GO TO OR WITH ORTHOPEDIC SURGEON, SURGEON USED TREPHINE DRILL TO REMOVE BROKEN CANNULA. WHEN USING THE DRILL, CANNULA BROKE AGAIN INSIDE THE PATIENT. REMAINING FRAGMENT OF CANNULA WAS ABLE TO BE REMOVED WITH FURTHER DRILLING USING THE TREPHINE DRILL. PT DID NOT EXPERIENCE ANY SIGNIFICANT BLOOD LOSS. CLOSURE WAS PERFORMED AND PT WAS KEPT OVERNIGHT FOR OBSERVATION. PT WAS DISCHARGED THE FOLLOWING DAY.
Patient problems: Foreign Body In Patient
MAUDE report 19903860 ↗
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.
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