Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchan

FDA device recall Z-3136-2017 · posted 2017-09-20 · Terminated

Recall details

Recalling firm

Medtronic Vascular Galway DBA Medtronic Ireland

Reason for recall

Stylette removal difficulties on the Euphora and Solarice products.

Action taken

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 Representative can assist you in the return and replacement of this product as necessary. 3. Complete the enclosed Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality or scan and email to RS.CFQFCA@medtronic.com. Medtronic is communicating this information to the U.S. FDA and other appropriate regulatory agencies as required. Please share this notification with others who need to be aware in your organization or to any organization where affected product may have potentially been transferred. We are committed to acting responsibly in the best interest of patient safety. We sincerely appreciate your patience as it relates to this matter. If you have any questions, please contact your Medtronic Field Representative or Technical Services at 1-877-526-7890 Ext. 27220. Adverse reactions or quality problems experienced with the use of this product may be reported to your Medtronic Representative and the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Root cause

Process design

Status

Terminated

Product code

LOX

Quantity affected

69,081 (US)

Distribution

Worldwide distribution. US Nationwide, including Puerto Rico; ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BARBADOS, BELGIUM, BOSNIA AND HERZEGOWINA, BRAZIL, BULGARIA, CANADA, CHINA, CO

Date initiated

2017-07-13

Date posted

2017-09-20

Date terminated

2020-08-19

Location

Galway, Ireland

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