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

Recalled May 18, 2022 · FDA recall Z-1043-2022 · Medtronic Vascular

Hazard

Packaging for Balloon Catheters may be damaged resulting in loss of sterility. · FDA Class II

Units

3 units

Sold at

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, Philippines, Poland, Portugal, Puerto Rico, Reunion, Russian Federation, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom.

Description

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

Product

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

Manufacturer(s)

Medtronic Vascular, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →