Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Check against the official notice below — it lists the full affected range.
Medtronic Vascular, Inc. is recalling 3 units of the Medtronic IN.PACT AV Paclitaxel-coated PTA Balloon Catheter (Reference IAV06008008P, Lot Number 0010990608) because the packaging may be damaged, which could result in loss of sterility. The affected product was distributed worldwide and across numerous U.S. states.
The recall notice does not specify a remedy or instructions for what consumers should do with the recalled product.
Written by software from the official notice below. Not reviewed by a lawyer.
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Reason for recall: Packaging for Balloon Catheters may be damaged resulting in loss of sterility. 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 Yo Quantity: 3 units Lot/code info: Lot Number: 0010990608/ GTIN: 00763000232580
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.