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SEPLOU
SEPLOU (ZHUHAI) CO.,LTD. · Model SPAS1250S · UDI-DI 06976358503835
FED
Prescription
10
510(k) clearances
1,312
Adverse events (22 deaths)
12
Recalls
116
Facilities
Description
The Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-19 | Calyxo, Inc. | Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosi |
| 2024-11-27 | Trokamed GmbH | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal |
| 2024-11-27 | Trokamed GmbH | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal |
| 2024-11-27 | Trokamed GmbH | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal |
| 2024-11-27 | Trokamed GmbH | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal |
| 2021-08-03 | Olympus Corporation of the Americas | Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection. |
| 2020-03-11 | Boddingtons Plastics Ltd | Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device) |
| 2013-11-05 | Boston Scientific Corporation | The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator. |
| 2013-11-05 | Boston Scientific Corporation | The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator. |
| 2013-11-05 | Boston Scientific Corporation | The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator. |
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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.