ERAGON MODULAR 83930072Recalls & reported problems
Richard Wolf GmbH · HANDLE PISTOL SHAPED with locking mechanism, without HF-connection, for use with all ERAGON outer sheath tubes, reusable · Class 2
All models of ERAGON MODULAR (16)
Data updated Oct 16, 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 04055207026601), received between Oct 18, 2018 and Oct 18, 2018 — classified as 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON SEPTEMBER 18, 2018, THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC): "TIP OF INSERT BROKE OFF IN PATIENT". WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. SPECIFICALLY, WAS THE DEVICE BEING USED ON A PATIENT WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO PATIENT OR OTHER PERSONNEL DUE TO ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED THAT PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. HOW WAS THE PATIENT ANESTHETIZED? UNKNOWN. RWMIC RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE REPORTED MALFUNCTION COULD NOT BE VERIFIED DURING EVALUATION. DEVICE WAS FOUND TO HAVE NO PROBLEM. NO MANUFACTURING DEFECT WAS IDENTIFIED DURING THE EVALUATION. THE OTHER COMPONENTS OF THE MODULAR SYSTEM, THE GRASPING FORCEP INSERT AND THE INSULATED SHEATH TUBE, ARE CONSIDERED SUSPECT DEVICES AND A REPORT WILL BE SUBMITTED FOR EACH DEVICE. GRASPING FORCEP INSERT - PRODUCT NUMBER 8393.292 (MDR 1418479-2018-00032). PISTOL SHAPED
Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient
MAUDE report 7982477 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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