Summary
The FDA issued a Class III for GreenLight HPSEA Laser Fibers, UPN 0010-2092 by Boston Scientific Corporation. Reason: Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Lase.
Details
Source
Device Recall
External ID
Z-1392-2022
Action Date
2022-07-27
Status
Ongoing
Category
device
Product Description
GreenLight HPSEA Laser Fibers, UPN 0010-2092
Lot/Code Info: UDI-DI (GTIN): 00878953005522 Lot: 27770466
Quantity Affected: 57
Reason for Recall
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.
Distribution
Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-31
Company
Marlborough, MA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 176 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Corporation have FDA actions?
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1392-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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