Bonopty Penetration Set G025Recalls & reported problems
Apriomed AB · Manually operated, sterile, single use coaxial bone biopsy system. · Class 1
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 07350031350258), received between Feb 19, 2026 and Feb 19, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2026Improper or Incorrect Procedure or Method
BONOPTY PENETRATION SET (CATALOGUE NO: 10-1072, LOT: 2441015) WAS USED. THE DEVICE WAS REPORTED TO BE VERY DIFFICULT TO REMOVE FROM THE PATIENT. UPON REMOVAL, IT WAS DISCOVERED THAT APPROXIMATELY 40 MM OF THE DISTAL PORTION OF THE DEVICE WAS MISSING. VIA AN ATTACHED IMAGE, IT WAS POSSIBLE TO VERIFY THAT THE AFFECTED COMPONENT IS APRIOMED COMPONENT 30348, PENETRATION CANNULA. THE EXACT SEQUENCE OF MOVEMENTS PERFORMED BY THE PRACTITIONER DURING REMOVAL IS UNKNOWN. THE RETAINED PORTION OF THE DEVICE REQUIRED SURGICAL INTERVENTION ON (B)(6) 2026 TO REMOVE IT FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFUL, AND THE PART WAS FULLY REMOVED. THE REPORTED PATIENT OUTCOME WAS HOSPITALIZATION.
Patient problems: Insufficient Information
MAUDE report 24387459 ↗
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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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