CLASS II ONGOING Device recall · Reported 2 Aug 2023 · FDA Enforcement Report
Flexiva Pulse 242 TracTip Single-Use Laser Fibers recalled
Boston Scientific is recalling Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that, distributed nationwide in the US. The recall was initiated on 25 May 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2229-2023
- FDA event ID
- 92570
- Recalling firm
- Boston Scientific, Marlborough, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 May 2023
- FDA classified
- 21 Jul 2023
- Reported
- 2 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 25 May 2023 | Recall initiated by company | |
| 21 Jul 2023 | Classified by FDA | +57 days |
| 2 Aug 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN : M006L8405960
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
GTIN: 08714729978619 Lot Number: 30389365, 30389368, 30389369, 30429826, 30479399, 30479580, 30479582, 30554453 Exp. Date: 20-Oct-2025 to 3-Nov-2025
Where was it sold?
Worldwide distribution - US Nationwide and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 92570This product is part of a recall event; the main page for the event is Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended recalled | Boston Scientific | Potency & Assay | Nationwide | |
| CLASS II | Flexiva Pulse ID-intended to be used as a device recalled | Boston Scientific | Potency & Assay | Nationwide | |
| CLASS II | Flexiva Pulse-Use Laser Fibers-intended to be used as recalled | Boston Scientific | Potency & Assay | Nationwide | |
| CLASS II | Flexiva Pulse ID-intended to be used as a device recalled | Boston Scientific | Potency & Assay | Nationwide | |
| CLASS II | Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be recalled | Boston Scientific | Potency & Assay | Nationwide | |
| CLASS II | Flexiva Pulse ID 242 TracTip single Use Fiber-intended recalled | Boston Scientific | Potency & Assay | Nationwide |
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