# FDA recall Z-1043-2022

> **Medtronic Vascular, Inc.** · Class II · device recall initiated 2022-03-23.

## Product

Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only

## Reason for recall

Packaging for Balloon Catheters  may be damaged resulting in loss of sterility.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware,  District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, PUERTO RICO, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, Colombia, Croatia	Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Republic Of Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Caledonia, New Zealand, Norway, Oman, Peru, Phi

## Key facts

- **Recall number:** Z-1043-2022
- **Recalling firm:** Medtronic Vascular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-23
- **Report date:** 2022-05-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Rosa, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1043-2022

## Citation

> AI Analytics. FDA recall Z-1043-2022. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1043-2022. Source: US FDA. Licensed CC0.

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