Unrated Medical device recall · FDA · Published May 4, 2021

Medtronic Vascular Angiographic Guidewire Component Recall: Risk of Improper Sterilization

Medtronic Vascular recalls angiographic guidewire components with model numbers 107042, 107044, etc. due to improper sterilization process. Affected items may not be safe for medical use.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1860-2021Medical device Medtronic Vascular ›

Recall notice

The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers.

Take action

Contact the company

Recalling firmMedtronic Vascular35-37A Cherry Hill Drive · Danvers, MA 01923-2565

✎ GovInfoNow plain-language explainer

Medtronic Vascular is recalling specific angiographic guidewire components that were shipped directly to customers instead of being processed for sterilization. This means the components may not be safe for medical use as they were not properly sterilized. Read more at govinfonow.com/recall/62608-medtronic-vascular-angiographic-guidewire-component-recall-risk-of-improper-sterilization.

Source Summary by GovInfoNow · govinfonow.com/recall/62608-medtronic-vascular-angiographic-guidewire-component-recall-risk-of-improper-sterilization · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1860-2021

Cite this page

“Medtronic Vascular Angiographic Guidewire Component Recall: Risk of Improper Sterilization.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62608-medtronic-vascular-angiographic-guidewire-component-recall-risk-of-improper-sterilization. Based on FDA recall #Z-1860-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1860-2021%22&limit=1).

Medtronic Vascular recalled Angiographic Guidewire Components on May 4, 2021, after they were shipped directly to customers instead of a third-party for required sterilization processing, the FDA said. The agency announced the Class I recall under number Z-1860-2021.

How to tell if you have it

Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004
UPC: 00673978284569, 00673978284576, 00673978284620, 00673978284729, 20613994885306, 20613994885337, 20613994885399, 20613994994534
Lot codes: GFRF0544 through GFZL0749 (full list in description)
Sold in CA, KY, LA, MI, NE, NY, OH, OK, TX, WA, WI and Australia

The hazard

The components were manufactured with a requirement that further downstream processing, specifically sterilization, is required. Because they were shipped directly to customers, the intended sterilization process was bypassed, leaving the devices unsterilized for their indicated use.

Context

GovInfoNow's records show Medtronic Vascular has 5 other recalls on record since 2018-03-13. Other recent recalls of similar products include Medtronic 6F Launcher Guide Catheter Recall (2021-01-15), Medtronic Vascular: Rashkind Balloon Catheters Recall (2020-08-25), and Medtronic Vascular SHERPA NX Catheter Recall (2019-03-15). Additional recent recalls of similar products include Medtronic DLP Retrograde Cannula Recall (2026-04-21), Medline ARTERIAL LINE INSERTION KIT Recall (2026-06-12), and Medline Convenience Kits Recall (2026-01-07).

How to tell if you have this one

Check for model numbers 107042, 107044, 107447, 110003, 110004 or serial numbers listed in the recall notice. These components are used in angiographic procedures and were shipped without proper sterilization.

Brand
Medtronic Vascular
Product
Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the model number or serial number on the component to determine if it is affected by this recall.

Where it went and when

Where it was distributed

Distributed in 11 states, and outside the U.S.

FDA distribution: “US /Domestic Distribution to states of: CA, KY, LA, MI, NE, NY, OH, OK, TX, WA, WI. OUS/Foreign to country of: Australia” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Kentucky, Louisiana, Michigan, Nebraska, New York, Ohio, Oklahoma, Texas, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

May 4, 2021Firm started the recall
Jun 16, 2021FDA classified it Class I
Jun 23, 2021Published in FDA’s Enforcement Report
Jan 5, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/62608-medtronic-vascular-angiographic-guidewire-component-recall-risk-of-improper-sterilization">Medtronic Vascular Angiographic Guidewire Component Recall: Risk of Improper Sterilization (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1860-2021 (May 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1860-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.