Recall Z-1043-2022 ยท PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter
Medtronic Vascular, Inc.
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
| Date | Mar 23, 2022 |
| Status | Open, Classified |
| Reason | Packaging for Balloon Catheters may be damaged resulting in loss of sterility. |
| Root 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 co |
| Quantity | 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, Minne |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.