Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cl
Summary
The FDA issued a Class II for Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device th by Boston Scientific Corporation. Reason: Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficienc.
Details
Source
Device Recall
External ID
Z-2234-2023
Action Date
2023-08-02
Status
Ongoing
Category
device
Product Description
Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy 5-pack UPN: M006L8406961
Lot/Code Info: GTIN: 08714729978763 Lot Numbers: 30389516, 30389520, 30389525, 30429871, 30479615 Exp. Date: 20-Oct-2025 to 3-Nov-2025
Quantity Affected: 280 units
Reason for Recall
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-25
Company
Marlborough, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-2234-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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