# FDA recall Z-1042-2022

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

## Product

Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P	ADM04008013P	ADM04008013P	ADM04008013P	ADM04012013P	ADM04015013P	ADM04015013P	ADM04025013P	ADM05004013P	ADM05004013P	ADM05006013P	ADM05006013P	ADM05008013P	ADM05008013P	ADM05020013P	ADM06004013P	ADM06004013P	ADM06006013P	ADM06006013P	ADM06008013P	ADM06012013P	ADM06015013P	ADM06015013P	ADM06015013P	ADM06015013P	ADM07004013P	ADM07006013P	ADM07006013P	ADM07008013P    SBI04004013P	SBI04008008P	SBI04012013P	SBI04015013P	SBI05004008P	SBI05006013P	SBI05012008P	SBI05012008P	SBI05012013P	SBI05015013P	SBI06004008P	SBI06004008P	SBI06004013P	SBI06004013P	SBI06006008P	SBI06006008P	SBI06008008P	SBI06008008P	SBI06012013P	SBI06012013S	SBI06015013P	SBI07004013P	SBI08004013P	SBI08008008S	SBI10004008P

## 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-1042-2022
- **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-1042-2022

## Citation

> AI Analytics. FDA recall Z-1042-2022. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1042-2022. Source: US FDA. Licensed CC0.

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