FDAFDA · Food and drugs·Recall number Z-1043-2022
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Published May 18, 2022 · Recall initiated: March 23, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Vascular, Inc.
- Distributor
- 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.
- Lot
- Lot Number: 0010990608/ GTIN: 00763000232580
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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