Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W05002

FDA device recall Z-0904-2025 · posted 2025-01-15 · Open, Classified

Recall details

Recalling firm

ev3 Inc

Reason for recall

There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.

Action taken

Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 12/10/2024 via mail courier. The notice explained the issue, potential harms, and requested the following actions be taken: "" Immediately locate and quarantine all affected and unused NanoCross devices as listed in the provided scope. " Return all unused affected products 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. " Complete and return the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information, and return it to RS.CFQFCA@medtronic.com within 30-days of receipt of this letter. " Please forward this notice to all those who need to be aware within your organization and maintain a copy for your records."

Root cause

Process change control

Status

Open, Classified

Product code

LIT

Quantity affected

5189 units

Distribution

Worldwide distribution - US (& PR) Nationwide and the countries of Chile, Cyprus, Estonia, Germany, Italy, Japan, Jordan, Puerto Rico, Spain, United States, Uzbekistan, and Yemen.

Date initiated

2024-12-10

Date posted

2025-01-15

Location

Plymouth, MN

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