Radial Jaw 4 M00515180Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729821717), received between Jan 4, 2018 and Feb 26, 2026 — classified as 2 deaths, 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 WAS USED IN A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, ONE OF THE JAWS OF THE RADIAL JAW 4 WAS NOT FUNCTIONING AND WAS UNABLE TO PERFORM THE BIOPSY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24464143 ↗
• InjuryOct 23, 2025Entrapment of Device; Difficult to Open or Close; Entrapment of Device; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 WAS USED IN THE LUNGS DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PROCEDURE, THE JAWS OF THE RADIAL JAW 4 WOULD NO LONGER CLOSE ON THE FIFTH REMOVAL OF SPECIMEN FOR BIOPSY. AS IT WAS RISKY TO REMOVE THE FORCEPS, THE PATIENT WAS INTUBATED TO AWAIT THE ARRIVAL OF THE THORACIC SURGEON FOR CONDUCT. THE PATIENT REQUIRED MECHANICAL VENTILATION AND WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU).

  Patient problems: Ventilator Dependent

  MAUDE report 23372968 ↗
• MalfunctionAug 9, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 PULMONARY FORCEPS WAS USED DURING A THORACOSCOPIC BIOPSY PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE FORCEPS COULD NOT BE CLOSED, AND BIOPSY COULD NOT BE EXTRACTED NORMALLY. THE PROCEDURE WAS COMPLETED USING ANOTHER RADIAL JAW 4 PULMONARY FORCEPS. THERE ARE NO KNOWN PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19950075 ↗
• MalfunctionApr 15, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 PULMONARY WAS USED IN A PULMONARY BIOPSY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE JAWS FAILED TO CLOSE ON THE SECOND PASS. A DIFFERENT DEVICE 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 19105551 ↗
• MalfunctionApr 8, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 PULMONARY BIOPSY FORCEPS WAS USED DURING A BIOPSY PROCEDURE PERFORMED IN THE BRONCHIAL TUBE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE JAWS OF THE BIOPSY FORCEPS WERE FOUND TO BENT WHEN IT REACHED THE TARGET AREA. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 PULMONARY BIOPSY FORCEPS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF PULL WIRE DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9935456 ↗
• InjuryFeb 6, 2020Adverse 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 PULMONARY BIOPSY FORCEPS WAS USED IN THE LUNGS DURING A BRONCHOSCOPY WITH BIOPSY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A BIOPSY WAS PERFORMED FOR A SUSPECTED MALIGNANT TUMOR. AFTER THE FIRST BIOPSY, THE SITE BEGAN TO BLEED. ICE WATER FLUSH WAS USED TO SLOW THE BLEEDING. A SECOND BIOPSY WAS THEN TAKEN AND MORE BLEEDING OCCURRED. ICE WATER FLUSHES WERE USED AGAIN. A RAPID RESPONSE TEAM WAS CALLED AND THE PATIENT WAS STABILIZED. THE PATIENT WAS THEN BROUGHT TO THE POST ANESTHESIA CARE UNIT AND WAS RELEASED FROM THE HOSPITAL ON THE SAME DAY. THERE WERE NO REPORTED ISSUES WITH THE DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9679710 ↗
• DeathFeb 6, 2020Adverse 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 PULMONARY BIOPSY FORCEPS WAS USED IN THE LUNGS DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS SUSPECTED TO HAVE A MALIGNANT TUMOR IN THE LUNG. DURING THE PROCEDURE, AFTER 12 BIOPSIES WERE TAKEN, THE PATIENT BEGAN TO BLEED. ICE WATER LAVAGE WAS USED TO SLOW THE BLEEDING AND THE SCOPE WAS REMOVED. THE PATIENT THEN BEGAN TO BLEED FROM THE NOSE AND MOUTH. THE PHYSICIAN WAS UNABLE TO RE-INTUBATE THE PATIENT. THE PATIENT WAS UNABLE TO BE RESUSCITATED. THE PATIENT EXPIRED AT APPROXIMATELY 12:30 ON (B)(6) 2020. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9679665 ↗
• MalfunctionDec 17, 2019Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 PULMONARY BIOPSY FORCEPS WAS USED IN THE LUNGS DURING A BIOPSY PROCEDURE PERFORMED IN (B)(6), 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE JAWS REMAINS IN SEMI OPEN POSITION AND WOULD NOT STAY CLOSE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED 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 9482062 ↗
• MalfunctionOct 7, 2019Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 PULMONARY BIOPSY FORCEPS WAS USED IN THE LUNGS DURING A BRONCHOSCOPY WITH ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED IN (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BIOPSY FORCEPS WAS USED TO OBTAIN THREE SPECIMENS SUCCESSFULLY. HOWEVER, WHILE TAKING THE FOURTH SPECIMEN, THE JAWS SPRUNG OPEN AND WOULD NO LONGER CLOSE. THERE WAS NO VISIBLE DAMAGE NOTED TO THE FORCEPS. THE FOURTH SPECIMEN WAS STILL ABLE TO BE REMOVED, AND THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9162108 ↗
• MalfunctionJul 24, 2019Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RADIAL JAW 4 PULMONARY BIOPSY FORCEPS WAS USED DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE JAWS WOULD NOT CLOSE WHEN IT WAS REINTRODUCE INTO THE SCOPE FOR ANOTHER BIOPSY. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 PULMONARY BIOPSY FORCEPS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8823380 ↗
• DeathMay 16, 2019Adverse 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 PULMONARY BIOPSY FORCEPS WAS USED IN A BRONCHOSCOPY PROCEDURE WITH LUNG MASS BIOPSY PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, BIOPSIES WERE TAKEN UNDER FLUOROSCOPY. ON THE THIRD BIOPSY, THE PATIENT BEGAN TO BLEED. THERE WAS NO ALLEGED MALFUNCTION OR DEFICIENCY OF THE RADIAL JAW 4 FORCEPS. TO CONTROL THE BLEEDING, EPINEPHRINE WAS INJECTED AND COLD SALINE WAS FLUSHED THROUGH THE BRONCHOSCOPE. DUE TO DECREASED SATURATION LEVELS, THE SCOPE WAS THEN REMOVED FROM THE PATIENT, AND AN AMBU BAG WAS USED. SATURATION LEVELS CONTINUED TO DROP, AND A CODE BLUE WAS CALLED. THE PATIENT WAS THEN INTUBATED, AND THE SCOPE WAS REINTRODUCED INTO THE PATIENT. UPON RE-BRONCHOSCOPY, A LARGE SADDLE-MASS WAS VISUALIZED OVERLYING THE MAIN CARINA OCCLUDING BOTH MAIN STEMS AND THE DISTAL END OF THE ET TUBE. NUMEROUS CLOTS WERE THEN REMOVED USING A TRAPEZOID BASKET AND RADIAL JAW 4 HOT FORCEPS, THOUGH THE LARGE MASS WAS NOT ABLE TO BE EXTRACTED. THE BLEEDING HAD SUBSIDED BY THIS POINT, AND IT WAS NOTED THAT THE LARGE CLOT REMAINED AS THE "INCITING CULPRIT". THE PATIENT CODED AGAIN. COLD SALINE WAS FLUSHED A

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8615694 ↗
• InjuryFeb 27, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW¿ 4 PULMONARY BIOPSY FORCEPS DEVICE WAS USED IN THE MAIN CARINA DURING AN AIRWAY BIOPSY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN TOOK APPROXIMATELY SEVEN BIOPSIES WITHOUT ISSUES. WHILE TRYING TO TAKE THE EIGHTH BIOPSY OF THE RIGHT UPPER LOBE, THE JAWS OF THE FORCEPS DEVICE WERE OUT OF VIEW OF THE SCOPE. THE PHYSICIAN THEN USED FLUOROSCOPY TO VIEW THE POSITION OF THE JAWS, AND FOUND THE JAWS WERE FOLDED IN A T-SHAPE. THE DEVICE WAS NOT ABLE TO BE REMOVED FROM THE BRONCHOSCOPE. THE HANDLE OF THE DEVICE WAS THEN CUT OFF OF THE WORKING LENGTH AND REMOVED FROM THE BRONCHOSCOPE, LEAVING THE FORCEPS DEVICE INSIDE THE PATIENT. THE BRONCHOSCOPE WAS REINSERTED ALONGSIDE THE FORCEPS WORKING LENGTH TO GET A BETTER VIEW OF THE JAWS. A ZERO TIP PULMONARY RETRIEVAL BASKET WAS THEN USED TO STRAIGHTEN THE JAWS IN ORDER TO REMOVE THE DEVICE, AND SUCCESSFULLY COMPLETE THE PROCEDURE. THE WHOLE PROCEDURE FROM START TO FINISH TOOK APPROXIMATELY TWO HOURS LONG. AFTER THE DEVICE WAS REMOVED FROM THE PATIENT, IT WAS NOTICED THAT THE PULL WIRE HAD BROKEN, ALLOWING THE JAWS TO FLOP T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7301611 ↗
• MalfunctionJan 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 PULMONARY BIOPSY FORCEPS WAS USED IN THE RIGHT LOWER LOBE (B8) DURING A TRANSBRONCHIAL LUNG BIOPSY (TBLB) AND BRONCHOALVEOLAR LAVAGE (BAL) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, RESISTANCE WAS FELT WHEN THE DEVICE WAS INSERTED THROUGH THE SCOPE, AND A BIOPSY WAS PERFORMED. WHEN THE DEVICE WAS RE-INSERTED INTO THE SCOPE FOR ANOTHER BIOPSY, RESISTANCE WAS FELT. THE DEVICE WAS REMOVED AND IT WAS FOUND THAT THE PULLWIRE WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW¿ 4 PULMONARY BIOPSY FORCEPS. ADDITIONALLY, AFTER THE PROCEDURE WHEN THE USED SCOPE WAS WASHED, THE BRONCHOSCOPE WAS FOUND TO BE LEAKING. THERE WERE NO PATIENT COMPLICATIONS REPORTED A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE ¿GOOD¿. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; FOREIGN MATTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7165425 ↗