Recall Z-3137-2017 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Medtronic Vascular Galway DBA Medtronic Ireland
Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
| Date | Sep 20, 2017 (initiated Jul 13, 2017) |
| Status | Terminated |
| Reason | Stylette removal difficulties on the Euphora and Solarice products. |
| Root cause | Process design |
| Action | Medtronic sent a communication informing their consignees about the recall and for the customers to take the following actions: Medtronics records indicate that your facility has received product potentially affected by this issue. As a result, Medtronic requests that you immediately take the following actions: 1. Identify and quarantine all unused affected product as listed in your inventory. 2. Return all unused affected listed product in your inventory to Medtronic. Contact Medtronic Customer Service at 888-283-7868 to initiate a product return and credit. Your local Medtronic Representa |
| Quantity | 105,633 (OUS) |
| Distribution | Worldwide distribution. US Nationwide, including Puerto Rico; ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BARBADOS, BELGIUM, BOSNIA AND HERZEGOWINA, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ESTONIA, FRANCE, GERMANY, GREAT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143480 | Euphora Rapid Exchange Balloon Dilatation Catheter Medtronic, Inc., Apr 2, 2015 |