Radial Jaw 4 M00513400Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729745662), received between Jan 9, 2019 and Sep 4, 2026 — classified as 6 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (5 reports).

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.

Recalls naming this device

1. Jun 30, 2026Class IIOpen, Classified

   Potential for breach in sterile barrier of device packaging.

   Z-2838-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported to Boston Scientific Corporation that a Radial Jaw 4 was used in the Upper and Lower GI during a Biopsy procedure.During the procedure, unexpected, severe bleeding occurred after the biopsy. The bleeding was treated by clipping and hemostasis-injection. The procedure was completed using the original device. The patient condition following procedure was stable.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50602481 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50600117 ↗
• MalfunctionAug 8, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 WAS INTENDED FOR USE IN A PROCEDURE ON (B)(6) 2025. PRIOR TO UNPACKING THE DEVICE, THE OUTER BAG WAS CHECKED AND AN OILY STAIN WAS NOTICED ON THE LABEL NEAR THE PROTECTIVE CAP AT THE TIP OF THE CUP. THE OILY BLOTCH WAS ALSO NOTED INSIDE THE PACKAGING ON THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22753006 ↗
• MalfunctionSep 25, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HAIR WAS FOUND IN THE RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS PACKAGING ON (B)(6) 2024. DURING UNPACKING, A HAIR APPEARS TO BE CAUGHT IN THE CRIMPED PART OF THE PACKAGING. THE PACKAGING HAS NOT BEEN OPENED. IT IS UNCLEAR WHETHER THE STERILITY WAS COMPROMISED OR NOT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304885 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS WAS USED IN THE DUODENUM DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE RADIAL JAW 4 TOOK TOO LARGE OF A BIOPSY. SUFFICIENT BIOPSY SAMPLES WERE TAKEN, AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE PATIENT WAS HOSPITALIZED BEYOND THE STANDARD OF CARE AND A REPEAT GASTROSCOPY WAS PERFORMED 48 HOURS LATER TO CONTROL BLEEDING AT THE SITE OF THE INITIAL BIOPSY. THE BLEEDING WAS TREATED WITH A CLIP. PATIENT HAS FULLY RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 18717165 ↗
• MalfunctionJan 11, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY FORCEPS WAS TO BE USED DURING A TISSUE BIOPSY ON (B)(6) 2023. DURING PREPARATION, THE NURSE WIPED THE RADIAL JAW 4 FORCEPS WITH A WET GAUZE AND FOUND BLACK MARKS ON IT. THE DOCTOR FELT UNCOMFORTABLE USING IT AND DECIDED NOT TO USE THE PRODUCT. ANOTHER RADIAL JAW 4 WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18495656 ↗
• MalfunctionOct 6, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY FORCEPS WAS USED DURING AN ENDOSCOPIC BIOPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, A WIRE WAS NOTICED AT THE BASE OF THE JAWS WHEN THE NURSE WAS RETRIEVING THE BIOPSY SAMPLES OUTSIDE OF THE PATIENT. THE WIRE WAS PULLED OFF THE DEVICE WITH NON-BIOPSY FORCEPS. NO FRAGMENTS WERE REPORTED, AND NOTHING DETACHED INSIDE THE PATIENT. IT IS UNKNOWN WHERE THE WIRE CAME FROM AND IF IT IS A COMPONENT OF THE DEVICE. AT THIS POINT, THE BIOPSY PORTION WAS ALREADY COMPLETED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17886103 ↗
• MalfunctionSep 6, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS WAS TO BE USED DURING A PROCEDURE ON (B)(6), 2023. PRIOR TO THE PROCEDURE WHEN PREPARING THE MEDICAL SUPPLIES FOR THE ENDOSCOPY ROOM, A HAIR WAS OBSERVED INSIDE THE PRODUCT PACKAGING. THERE WAS NO PATIENT INVOLVEMENT REPORTED FOR THIS EVENT AS THIS HAPPENED PRIOR TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695268 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; 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 COLON DURING A DIAGNOSTIC COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PATIENT EXPERIENCED BLEEDING AND A HEMATOMA. A RESOLUTION 360 CLIP WAS PLACED TO STOP THE BLEEDING. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS DISCHARGED ON AN UNKNOWN DATE. NO OTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS REPORTED THAT THE PATIENT FULLY RECOVERED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15725655 ↗
• MalfunctionAug 18, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 SC BIOPSY FORCEPS WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, A METAL SPLINTER WAS NOTED WHEN THE JAWS OF THE FORCEPS CAME OUT OF THE WORKING CHANNEL. A PHOTO PROVIDED BY THE CUSTOMER CONFIRMED THIS EVENT. THE BIOPSY FORCEPS WAS REMOVED AND ANOTHER RADIAL JAW 4 SC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15250616 ↗
• MalfunctionJun 16, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS WAS USED IN A PROCEDURE PERFORMED ON (B)(6)2022. DURING PREPARATION, A HAIR WAS FOUND ON THE DEVICE. THE DEVICE WAS NOT USED AND ANOTHER RADIAL JAW 4 BIOPSY FORCEPS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14717978 ↗
• MalfunctionFeb 28, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS WAS TO BE USED IN A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, THE PHYSICIAN NOTICED THAT THERE WAS SOMETHING LIKE WOOD SHAVINGS INSIDE THE STERILE AREA OF THE PACKAGING. ANOTHER RADIAL JAW 4 BIOPSY FORCEPS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13625390 ↗
• MalfunctionDec 7, 2021Entrapment of Device; Material Integrity Problem; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available; Entrapment of Device; Material Integrity Problem; 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 A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BIOPSY FORCEPS GOT STUCK IN THE INSERTION PORT OF THE ENDOSCOPE. FLUOROSCOPY NOTED DEFORMATION AROUND THE BASE OF THE CUPS. THE SCOPE COULD NO LONGER BE USED; THEREFORE, THE PROCEDURE WAS ABORTED. THE ENDOSCOPE WAS SENT TO THE MANUFACTURER FOR INVESTIGATION, TOGETHER WITH THE BIOPSY FORCEPS THAT COULD NOT BE REMOVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12955252 ↗
• InjuryJul 31, 2019Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FORCEPS TOOK SO MUCH TISSUE THAT SEVERE BLEEDING OCCURRED AFTER TAKING A BIOPSY IN THE ESOPHAGUS. THE PROCEDURE WAS COMPLETED AT THIS TIME, AND THE PATIENT STAYED ONE DAY IN THE HOSPITAL FOR MONITORING. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8848358 ↗
• MalfunctionJun 10, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS WAS UNPACKED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THE DEVICE PACKAGING WAS FOUND DAMAGED AND STERILITY OF THE DEVICE WAS COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 STANDARD CAPACITY 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 8684684 ↗
• InjuryJan 9, 2019Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS WAS USED IN A PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE FORCEPS CUT TOO DEEPLY. POST PROCEDURE, THE PATIENT EXPERIENCED A GI BLEED AND WAS SENT TO THE HOSPITAL. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8231544 ↗