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Single-use Extraction Baskets

Scivita Medical Technology Co., Ltd. · Model EBT-08 · UDI-DI 06971381251647

FFL Prescription

510(k) clearances

6,119

Adverse events (5 deaths)

Recalls

104

Facilities

Description

The product is composed of basket assembly, sheath assembly and handle assembly. This product is intended to capture, manipulate and remove stones and other foreign bodies during urinary diagnosis and treatment under endoscope.

Recalls

Date	Firm	Reason
2023-06-22	Wilson-Cook Medical Inc.	Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical litho
2023-06-22	Wilson-Cook Medical Inc.	Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical litho
2022-02-07	Philips North America, LLC	Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
2014-10-07	C.R. Bard, Inc.	The product is non-sterile.
2008-08-08	Sterilmed Inc	SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility e
2005-12-20	Boston Scientific Corp	The basket wire assembly may detach from the drive wire while in the patient.
2005-12-20	Boston Scientific Corp	The basket wire assembly may detach from the drive wire while in the patient.
2004-10-27	Cardinal Health	The dispenser box was mislabeled with the wrong length and the wrong wire gauge.
2003-12-22	C.R. Bard, Inc., Urological Division	Product packaging may contain holes compromising sterility.
2003-12-22	C.R. Bard, Inc., Urological Division	Product packaging may contain holes compromising sterility.

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Data 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.