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ERAGON MODULAR
Richard Wolf GmbH · Model 8396902 · UDI-DI 04055207056271
10
510(k) clearances
2,711
Adverse events (17 deaths)
11
Recalls
190
Facilities
Description
SHEATH TUBE Ø 10MM SL 447MM Compatible with all ERAGONmodular 10mm inserts in the respective sheath length, along with ERAGONmodular and ERAGONaxial handles without an HF connection, reusable
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-30 | Boston Scientific Corporation | Potential for breach in sterile barrier of device packaging. |
| 2026-06-30 | Boston Scientific Corporation | Potential for breach in sterile barrier of device packaging. |
| 2026-06-30 | Boston Scientific Corporation | Potential for breach in sterile barrier of device packaging. |
| 2023-03-24 | Richard Wolf GmbH | Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be open |
| 2023-03-24 | Richard Wolf GmbH | Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be open |
| 2023-03-24 | Richard Wolf GmbH | Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be open |
| 2023-03-24 | Richard Wolf GmbH | Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be open |
| 2016-04-15 | Cook Inc. | Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a devi |
| 2010-05-06 | Boston Scientific Corporation | Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result. |
| 2010-05-06 | Boston Scientific Corporation | Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.