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Zebra Guidewire for Urinary Tract

SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD. · Model UMW-32150A · UDI-DI 06976055232991

OCY Prescription

510(k) clearances

1,653

Adverse events (3 deaths)

Recalls

Facilities

Description

The product is divided into hydrophobic type and mixed type. The hydrophobic type guidewire consists of a nitinol core wire, a Polytetrafluoroethylene (PTFE) cladding (applied to the entire wire) with no coating on the surface and a soft tip containing a stainless steel spring; The mixed type guidewire consists of a nitinol core wire, a Polytetrafluoroethylene (PTFE) cladding (applied to the part except the distal end), and a polyurethane containing tungsten (PU) cladding with hydrophilic coating on the surface (applied to the prat of distal end 60mm).

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.