Radial Jaw 4 M00513360Recalls & 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729745600), received between Sep 1, 2023 and Apr 24, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jun 30, 2026Class IIOpen, Classified
Potential for breach in sterile barrier of device packaging.
Z-2840-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Device Contamination with Chemical or Other Material1
- Difficult to Remove1
- Material Integrity Problem1
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.
MalfunctionApr 24, 2026Difficult to Remove; Material Integrity Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE JUMBO FORCEPS WAS PULLED OUT FROM THE ENDOSCOPE, IT APPEARED TO BE CAUGHT IN THE AREA WHERE IT WILL BE INSERTED INTO FORCEPS CHANNEL AND COULD NOT BE PULLED OUT. INSERTION AND PULLING OUT OPERATION WERE REPEATEDLY PERFORMED SEVERAL TIMES, BUT IT STILL COULD NOT BE REMOVED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24987605 ↗MalfunctionSep 1, 2023Break; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; Break; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT WERE A RADIAL JAW WAS USED IN THE COLON ON A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING PROCEDURE, A WIRE WAS OBSERVED EXTENDING FROM THE SIDE OF THE FORCEPS, ALONG WITH A WHITE PLASTIC PIECE. ANOTHER TRAPEZOID RX BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17672664 ↗
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
- NA 8735685Richard Wolf GmbH · FORCEPS, BIOPSY, NON-ELECTRIC1 recall1 report
- NA 829051Richard Wolf GmbH · FORCEPS, BIOPSY, NON-ELECTRIC1 recall0 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 · each recall links to the FDA recall notice
- 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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