Medtronic Angiographic Guidewire Components Shipped Without Required Sterilization

Plain-English summary

Medtronic Vascular recalled approximately 54,997 angiographic guidewire component parts (Model Numbers 107042, 107044, 107447, 110003, and 110004) in a Class I recall. These components are intended for use in angiographic medical procedures.

These component parts are manufactured with a requirement for further downstream processing and sterilization before clinical use. Instead of being shipped to a third-party for the required processing, the components were shipped directly to customers. This means the distributed units may not have undergone the intended sterilization process.

The affected units were distributed domestically to California, Kentucky, Louisiana, Michigan, Nebraska, New York, Ohio, Oklahoma, Texas, Washington, and Wisconsin, as well as internationally to Australia. Specific lot numbers are identified in the recall documentation.

Unsterilized guidewire components pose a significant risk because these devices must be sterile when used internally during medical procedures to prevent patient infection.

The recalled product

Product

Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that further downstream processing (sterilization) is required. Indications for use fo

Manufacturer

Medtronic Vascular

Category

Medical Device — Interventional Cardiology / Angiography

Hazard

• improper-sterilization
• infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Related recalls