Radial Jaw 4 M00513390Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729745655), received between Jul 20, 2021 and May 17, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Difficult to Remove1
- Entrapment of Device1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 17, 2024Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS WAS USED IN THE ESOPHAGUS DURING A BIOPSY PROCEDURE PERFORMED ON (B)96) 2024. DURING THE PROCEDURE, THE FORCEPS COULD NOT BE REMOVED FROM THE FORCEPS CHANNEL AFTER ESOPHAGEAL BIOPSY. THE USER TRIED TO PUSH TOWARDS THE TIP, BUT IT COULD NOT BE PUSHED OUT. THE PROCEDURE WAS CANCELED AS THE ENDOSCOPE BECAME UNUSABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19341832 ↗MalfunctionJul 20, 2021Difficult to Remove; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS WAS USED IN THE STOMACH DURING AN ENDOSCOPIC BIOPSY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE FORCEPS WAS TRIED TO BE PULLED OUT ON THE FOURTH BIOPSY, THE FORCEPS GOT STUCK IN THE ENDOSCOPE. THE HANDLE WAS CUT AND THE CATHETER WAS PULLED BY HAND TO REMOVE THE DEVICE FROM THE SCOPE. THE SCOPE COULD NO LONGER BE USED; THEREFORE, THE PROCEDURE WAS ABORTED. A PHOTO SUBMITTED BY THE CUSTOMER SHOWED THAT THE CLEVIS ARMS WAS BENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12198351 ↗
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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