Agency classClass IOur severity:Severe FDA (Devices)·Z-1860-2021·Announced 2021-06-23

Medtronic Angiographic Guidewire Components Shipped Without Required Sterilization

Medtronic Vascular recalled 54,997 angiographic guidewire components that were shipped directly to customers without the required downstream processing and sterilization. The components should have been sent to a third-party processor first.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This FDA Class I recall meets the Severe severity threshold according to the rubric, which mandates a minimum score of 4 for any FDA Class I recall. Unsterilized medical components shipped without required processing represent a significant patient safety risk.

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…
Manufacturer: Medtronic Vascular
Category: Medical Device — Interventional Cardiology / Angiography
Hazard: improper-sterilization
infection-risk
Affected units: 54,997

Is your product affected?

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

Lot numbers (7)

GTIN: 00673978284569
20613994885306
00673978284576
00673978284620
20613994885337
00673978284729
20613994885399

Distribution

Distributed in 11 states:

Same manufacturer · Medtronic Vascular

See all →

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Same hazard · improper sterilization