Class 2 Device Recall Medtronic IN.PACT AV, Paclitaxelcoated PTA Balloon Catheter

• Date Initiated by Firm: March 23, 2022
• Create Date: May 06, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1043-2022
• Recall Event ID: 89935
• PMA Number: P190008
• Product Classification: Drug-coated peripheral transluminal angioplasty catheter - Product Code PRC
• Product: Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
• Code Information: Lot Number: 0010990608/ GTIN: 00763000232580
• Recalling Firm/ Manufacturer: Medtronic Vascular, Inc.; 3576 Unocal Pl; Santa Rosa CA 95403-1774
• For Additional Information Contact: Medtronic Vascular Customer Service; 800-716-6700
• Manufacturer Reason for Recall: Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
• FDA Determined Cause: Packaging process control
• Action: On March 23, 2022 Medtronic issued a "Urgent: Medical Device Recall" notification to affected consignees. In addition to informing consignees about the recalled product, Medtronic ask consignees to take the following actions: 1. Identify and quarantine all unused affected IN.PACT Admiral and IN.PACT AV catheters as listed in Table 1. 2. Return all unused affected product in your inventory to Medtronic. Contact Medtronic Vascular Customer Service at 800-716-6700 to initiate a product return. Your local Medtronic Representative can assist you with the initiation of the return. 3. Please complete the enclosed Customer Confirmation Form and email to rs.cfqfca@medtronic.com. 4. This notice should be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records.
• Quantity in Commerce: 3 units
• 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, Philippines, Poland, Portugal, Puerto Rico, Reunion, Russian Federation, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = PRC and Original Applicant = Medtronic Vascular Inc.