Radial Jaw 4Recalls & reported problems across all models
Boston Scientific Corporation · 15 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name at least one Radial Jaw 4 model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 132
- Deaths reported
- 2
- Injuries reported
- 36
- Recalls
- 3
We found 15 models of Radial Jaw 4 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 132 adverse event reports in the FDA's MAUDE database, received between Jun 7, 2016 and Sep 14, 2026 — classified as 2 deaths, 36 injuries, 93 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (32 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Radial Jaw 4 recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 ↗
- Jun 30, 2026Class IIOpen, Classified
Potential for breach in sterile barrier of device packaging.
Z-2839-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- Jun 30, 2026Class IIOpen, Classified
Potential for breach in sterile barrier of device packaging.
Z-2838-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
Most reported Radial Jaw 4 problems
Device problems
- Device Contamination with Chemical or Other Material32
- Adverse Event Without Identified Device or Use Problem27
- Tear, Rip or Hole in Device Packaging26
- Difficult to Open or Close14
- Break12
- Device Contaminated During Manufacture or Shipping8
- Entrapment of Device6
- Detachment of Device or Device Component4
Patient problems
- No Clinical Signs, Symptoms or Conditions43
- No Patient Involvement28
- No Consequences Or Impact To Patient23
- Hemorrhage/Blood Loss/Bleeding21
- No Known Impact Or Consequence To Patient4
- Unspecified Tissue Injury4
- Blood Loss3
- Foreign Body In Patient3
Radial Jaw 4 models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Radial Jaw 4 M00513410FORCEPS, BIOPSY, NON-ELECTRIC1 recall24 reports
- Radial Jaw 4 M00513330FORCEPS, BIOPSY, NON-ELECTRIC1 recall19 reports
- Radial Jaw 4 M00513400FORCEPS, BIOPSY, NON-ELECTRIC1 recall16 reports
- Radial Jaw 4 M00513320FORCEPS, BIOPSY, NON-ELECTRIC1 recall3 reports
- Radial Jaw 4 M00513360FORCEPS, BIOPSY, NON-ELECTRIC1 recall2 reports
- Radial Jaw 4 M00515030FORCEPS, BIOPSY, ELECTRIC29 reports
- Radial Jaw 4 M00515180FORCEPS, BIOPSY, BRONCHOSCOPE (NON-RIGID)2 deaths13 reports
- Radial Jaw 4 M00513440FORCEPS, BIOPSY, NON-ELECTRIC10 reports
- Radial Jaw 4 M00513300FORCEPS, BIOPSY, NON-ELECTRIC4 reports
- Radial Jaw 4 M00513380FORCEPS, BIOPSY, NON-ELECTRIC4 reports
- Radial Jaw 4 M00513450FORCEPS, BIOPSY, NON-ELECTRIC3 reports
- Radial Jaw 4 M00513390FORCEPS, BIOPSY, NON-ELECTRIC2 reports
- Radial Jaw 4 M00513310FORCEPS, BIOPSY, NON-ELECTRIC1 report
- Radial Jaw 4 M00513370FORCEPS, BIOPSY, NON-ELECTRIC1 report
- Radial Jaw 4 M00515200FORCEPS, BIOPSY, BRONCHOSCOPE (NON-RIGID)1 report
Recent Radial Jaw 4 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755035 ↗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 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 ↗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 ↗InjuryMar 4, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 WAS USED IN THE STOMACH DURING A ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, AT THE SECOND BIOPSY ATTEMPT, THE METAL JAWS OF THE BIOPSY FORCEPS DISENGAGED FROM THE CATHETER AND BROKE OFF INTO THE PATIENT. A BRONCHOSCOPY WAS PERFORMED TO ENSURE NO PIECES WERE ASPIRATED INTO THE AIRWAY. 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 24505427 ↗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 ↗MalfunctionJan 30, 2026
RADIAL JAW/BIOPSY FORCEPS PLACED DOWN SCOPE, NOT NOTED UNTIL PRESENTATION AT END OF SCOPE A SLIVER OF METAL PROTRUDING FROM FORCEPS GRASPER, IMMEDIATELY REMOVED AND NEW FORCEPS USED WITHOUT FURTHER INCIDENT DURING CASE OR HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24220591 ↗MalfunctionDec 8, 2025Break
DEVICE BROKE BEFORE ENTERING THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23735984 ↗MalfunctionNov 14, 2025Difficult 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 TO BE USED IN THE AIRWAY DURING A BRONCHIAL EXAMINATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION, THE RADIAL JAW 4 COULD NOT GRAB. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS 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 Clinical Signs, Symptoms or Conditions
MAUDE report 23551359 ↗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 ↗MalfunctionOct 22, 2025Difficult to Open or Close; Physical Resistance/Sticking
FROM STAFF: FORCEPS NOT FULLY OPENING STUCK CLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23356515 ↗MalfunctionSep 15, 2025Detachment of Device or Device Component
DURING THE EGD [ESOPHAGOGASTRODUODENOSCOPY], OPENED AN UNUSED STANDARD BIOPSY FORCEP, GAVE IT TO THE PHYSICIAN WHO THREAD THE FORCEP INTO THE SCOPE AND WHEN THE FORCEP WAS OPENED, A TINY PIECE OF (WHAT LOOKED LIKE) METAL CAME OUT OF THE END OF THE FORCEP/ GRASPER PART. THE PHYSICIAN WAS ABLE TO RETRIEVE THE WHOLE PIECE RIGHT AWAY AND NO DAMAGE TO THE PATIENT WAS DONE FROM IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23050929 ↗MalfunctionAug 19, 2025Mechanical Problem; Product Quality Problem; Structural Problem
NEEDED TO TAKE BIOPSIES DURING AN ENDOSCOPY. BIOPSY FORCEPS PACKAGE OPENED AND FORCEPS WERE FOUND TO HAVE JAWS LOCKED IN OPEN POSITION AND WHEN HANDLE OPEN AND CLOSED, THE JAWS MOVED SIDE TO SIDE, DID NOT OPEN AND CLOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22838764 ↗
Other Boston Scientific Corporation products
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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