Radial Jaw 4 M00513440Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729826767), received between Mar 15, 2018 and Aug 18, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (7 reports).

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

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50306565 ↗
• MalfunctionAug 17, 2026Device Contamination with Chemical or Other Material

  It was reported to Boston Scientific Corporation that a Radial Jaw 4 was used during an Endoscopic Biopsy procedure performed on (b)(6)2026.During the procedure, upon unpacking the device, white and thin fibers were found adhered to the distal cup when the protective tip cover was removed. The procedure was completed using another of the same device. There were no patient complications as the result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50274599 ↗
• MalfunctionJul 27, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, A PIECE OF METAL WAS NOTED INSIDE THE PACKAGING WITH THE DEVICE. DEVICE WAS NOT USE AND ANOTHER TRAPEZOID RX BASKET WAS OPENED 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 17407209 ↗
• MalfunctionFeb 20, 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 BIOPSY FORCEPS WAS TO BE USED IN A PROCEDURE ON AN UNKNOWN DATE. AS THE RADIAL JAW 4 WAS UNPACKED, FOREIGN MATTER WAS OBSERVED AT THE TIP OF THE DEVICE. ANOTHER OF SAME DEVICE 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 16405017 ↗
• MalfunctionDec 24, 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 BIOPSY FORCEPS WAS TO BE USED IN A BIOPSY PROCEDURE PERFORMED ON (B)(6), 2022. DURING THE PROCEDURE, THE FORCEPS' MIDSECTION AND TIP HAD WHAT APPEARED TO BE A BIT OF METAL ATTACHED TO IT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16045790 ↗
• InjuryMay 28, 2021Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 PEDIATRIC BIOPSY FORCEPS WAS USED DURING A BIOPSY PROCEDURE PERFORMED IN THE BRONCHIAL TUBE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PULL WIRE BROKE CAUSING THE JAWS TO HANG FROM THE CATHETER AND GET STUCK ON THE BRONCHI. IT WAS NOTED THAT THE JAWS DID NOT DETACH INSIDE THE PATIENT. FORCE WAS USED TO PULL THE RADIAL JAW 4 PEDIATRIC BIOPSY FORCEPS FROM THE PATIENT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. AFTER THE PROCEDURE, THE PATIENT HAD A PNEUMOTHORAX AND WAS TREATED WITH CONSERVATIVE THERAPY. THE DETAILS REGARDING THE TYPE OF CONSERVATIVE THERAPY TREATMENT PROVIDED TO THE PATIENT WERE NOTED AS UNKNOWN. THE PHYSICIAN SUSPECTED THAT THE JAWS MIGHT HAVE CAUSED THE PNEUMOTHORAX.

  Patient problems: Pneumothorax

  MAUDE report 11901369 ↗
• InjuryMay 23, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 GASTROPEDIATRIC BIOPSY FORCEPS WAS USED IN THE RIGHT LOWER LOBE OF THE LUNGS DURING A PLEURAL BIOPSY OF CARCINOMATOUS PLEURISY PROCEDURE PERFORMED ON (B)(6) 2019 ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FORCEPS WAS USED TO PERFORMED PLEURAL BIOPSY ON A LESION ABOUT FIFTEEN TIMES. THE SCOPE WAS THEN TURNED OVER TO ANOTHER LESION FOR ANOTHER BIOPSY; HOWEVER, THE HANDLE OF THE FORCEPS FELT HARD WHEN ACTUATING. UPON CLOSING THE FORCEPS, THE PULL WIRE BROKE AND DETACHED INTO THE PATIENT. A NON-BSC FORCEPS WAS USED TO REMOVE THE DETACHED PULL WIRE, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8636062 ↗
• MalfunctionJan 15, 2019Device 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 PEDIATRIC BIOPSY FORCEPS WAS USED DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN OPENING THE CUPS INSIDE THE PATIENT, AN OBJECT THAT LOOKS LIKE A LOOSE THREAD WAS FOUND ATTACHED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO FOREIGN OBJECT WAS DETACHED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8248810 ↗
• MalfunctionDec 4, 2018Device 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 PEDIATRIC BIOPSY FORCEPS WAS USED IN A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ON THE ENDOSCOPE IMAGE, A STRING/THREAD LIKE TINY OBJECT, SIMILAR TO LINT, WAS OBSERVED ON THE CUP WHEN OPENING THE FORCEPS. ANOTHER RADIAL JAW 4 PEDIATRIC BIOPSY FORCEPS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8130676 ↗
• MalfunctionMar 15, 2018Device 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 GASTRO PEDIATRIC BIOPSY FORCEPS WAS GOING TO BE USED IN THE BILE DUCT FOR A BIOPSY PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION PRIOR TO THE PROCEDURE, A HUMAN HAIR WAS FOUND HALF SEALED INSIDE THE STERILE POUCH. NO DAMAGE WAS NOTED ON THE STERILE SEAL OR DEVICE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW¿ 4 GASTRO PEDIATRIC BIOPSY FORCEPS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7342362 ↗