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Optimos™ Guidewire

TAEWOONGMEDICAL.CO.,LTD · Model GW2-45S · UDI-DI 08809744979953

OCY Prescription

510(k) clearances

1,635

Adverse events (3 deaths)

Recalls

Facilities

Description

The Optimos™ Guidewire is used to provide access to GI tract for the purpose of passing or exchanging endoscopic accessories.

Recalls

Date	Firm	Reason
2022-08-16	Cook Incorporated	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may
2019-01-04	Cook Inc.	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
2019-01-04	Cook Inc.	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
2019-01-04	Cook Inc.	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
2019-01-04	Cook Inc.	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
2019-01-04	Cook Inc.	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
2019-01-04	Cook Inc.	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
2019-01-04	Cook Inc.	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
2019-01-04	Cook Inc.	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
2014-03-31	NEO METRICS, INC.	Neo Metrics, Inc. is recalling NovaGold Guidewire because the tip may uncoil and / detach more frequently than anticipated. There have been no reports of illness or injury.

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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.