Z-2231-2023Class II

Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser...

Name: Z-2231-2023 Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser...
Creator: Boston Scientific Corporation
Published: 2023-05-25
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2023-05-25 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN... on 2023-05-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2231-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-25
Posted: 2023-07-21
Recalling firm: Boston Scientific Corporation
Product: Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L8406910
Product code: GEX Powered Laser Surgical Instrument
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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Boston Scientific issued Urgent Medical Device Product Removal letter dated May 25, 2023. via Fed'X. Letter states reason for recall, health risk and action to take: Further distribution or use of any remaining product affected by this removal should cease immediately. Please read the rest of this letter carefully and immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. Share this notice with any health care professional within your organization and with any organization where the affected devices may have been transferred. If you are a distributor, this notification must be forwarded to your customers to ensure notification of this product removal is carried out to the end-user level. If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. Please read carefully through the Removal Instructions included with this notification. Your local sales representative can answer any questions you may have regarding this notification. The Reply Verification Tracking Form (RVTF) enclosed with this Removal Notice must be completed and returned even if you do not have any units from affected lots. 1. Immediately discontinue use and segregate affected product. 2. Complete and return the RVTF to get a Return Goods Authorization (RGA) number. Indicate the quantity of SINGLE units you will be returning for credit If you have product that is listed in Table 1 (Affected Products) that is not included on your RVTF, provide the material number, lot number, and quantity you intend to return on your RVTF Return the RVTF via: Email: [email protected] or Fax: BSC Field Action Center 1-763-415-7708 3. Once Boston Scientific receives your completed RVTF, you will be contacted within 2 business days and provided an RGA number for product return. and ship affected p
Quantity in commerce: 112 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: GTIN: 08714729978671 Lot Numbers: 30389427, 30389429, 30389431, 30521475, 30521476, 30521477 Exp. Date: 20-Oct-2025 to 10-Nov-2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2231-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2228-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-21
Z-2229-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-21
Z-2230-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-21
Z-2231-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-21
Z-2232-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-21
Z-2233-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-21
Z-2234-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-21

Product code GEX

K210925Class IIFlexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser FiberBoston Scientific / cleared 2021-04-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)