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

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.