# FDA recall Z-1860-2021

> **Medtronic Vascular** · Class I · device recall initiated 2021-05-04.

## 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 for these components are not defined as they are not intended for final use.

## Reason for recall

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.

## Distribution

US /Domestic Distribution to states of: CA, KY, LA, MI, NE, NY, OH, OK, TX, WA, WI. OUS/Foreign to country of: Australia

## Key facts

- **Recall number:** Z-1860-2021
- **Recalling firm:** Medtronic Vascular
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-04
- **Report date:** 2021-06-23
- **Termination date:** 2023-01-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Danvers, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1860-2021

## Citation

> AI Analytics. FDA recall Z-1860-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1860-2021. Source: US FDA. Licensed CC0.

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