Radial Jaw 4 M00513310Recalls & reported problems
Boston Scientific Corporation · Single-Use Biopsy Forceps · Class 1
All models of Radial Jaw 4 (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729745501), received between Jan 31, 2020 and Jan 31, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
- Difficult to Open or Close1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 31, 2020Break; Difficult to Open or Close; Break; Difficult to Open or Close
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 LARGE CAPACITY BIOPSY FORCEPS WAS USED IN THE BRONCHUS INTERMEDIUS DURING AN ENDOBRONCHIAL BIOPSY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE FIRST BIOPSY WAS TAKEN WITHOUT ANY ISSUES. THE BIOPSY FORCEPS WAS REINTRODUCED INTO THE CHANNEL FOR ANOTHER BIOPSY SAMPLE. HOWEVER, UPON ATTEMPTING TO CLOSE THE JAWS, THE JAWS FAILED TO CLOSE AND "INTERNAL PARTS CAME OUT." A PHOTOGRAPH OF THE DEVICE SHOWED THE PULL WIRES WERE DISCONNECTED FROM THE JAWS AND EXTENDING OUT OF THE DISTAL END OF THE DEVICE. THE BIOPSY FORCEPS WERE REMOVED TOGETHER WITH THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 BIOPSY FORCEPS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9655725 ↗
Other FORCEPS, BIOPSY, NON-ELECTRIC devices
- Radial Jaw 4 M00513410Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall24 reports
- Radial Jaw 4 M00513330Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall19 reports
- Radial Jaw 4 M00513400Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall16 reports
- NA 8736685Richard Wolf GmbH · FORCEPS, BIOPSY, NON-ELECTRIC1 recall15 reports
- NA 828051Richard Wolf GmbH · FORCEPS, BIOPSY, NON-ELECTRIC1 recall6 reports
- Radial Jaw 4 M00513320Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall3 reports
- Radial Jaw 4 M00513360Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall2 reports
- NA 8735685Richard Wolf GmbH · FORCEPS, BIOPSY, NON-ELECTRIC1 recall1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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