Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

GreenLight HPSEA Laser Fibers Recalled by Boston Scientific Corporation Due to Several complaints were received for the affected lot;...

Date: May 31, 2022
Company: Boston Scientific Corporation
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.

Affected Products

GreenLight HPSEA Laser Fibers, UPN 0010-2092

Quantity: 57

Why Was This Recalled?

Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and fiber card. This may result in prolonged procedure while the fiber is being replaced.

Where Was This Sold?

This product was distributed to 7 states: AR, CA, IL, ME, MI, NC, TX

Affected (7 states)Not affected

About Boston Scientific Corporation

Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report