Radial Jaw 4 M00515200Recalls & reported problems

Boston Scientific Corporation · Single-Use Biopsy Forceps · Class 2

All models of Radial Jaw 4 (15)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729821748), received between Nov 14, 2025 and Nov 14, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Difficult to Open or Close1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

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 ↗

Device details

UDI-DI	`08714729821748`
Brand	Radial Jaw 4
Model	M00515200
Company	Boston Scientific Corporation
Product code	BWH · FORCEPS, BIOPSY, BRONCHOSCOPE (NON-RIGID)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 20, 2026

Device type (GMDN): Flexible endoscopic biopsy forceps, single-use

A flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device.

Other FORCEPS, BIOPSY, BRONCHOSCOPE (NON-RIGID) devices

Radial Jaw 4 M00515180
Boston Scientific Corporation · FORCEPS, BIOPSY, BRONCHOSCOPE (NON-RIGID)
2 deaths13 reports

All FORCEPS, BIOPSY, BRONCHOSCOPE (NON-RIGID) devices →

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
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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