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FUJIFILM
FUJIFILM CORPORATION · Model TS-12140 · UDI-DI 04547410331493
FED
Prescription
1
510(k) clearances
1,336
Adverse events (22 deaths)
12
Recalls
117
Facilities
Description
These sterile Over-tubes are intended to be used as accessories with the FUJINON/ FUJIFILM Double Balloon Endoscopes cleared for use with Over-tubes. The Over-tubes are used to assist with the movement of the scopes inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children.
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.