Recall record at a glance
| Official record | Z-2228-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Boston Scientific Corporation |
| Report date | Aug 2, 2023 |
| Recall initiation date | May 25, 2023 |
| Quantity | 66 units |
| Location | Marlborough, MA, United States |
Official product description
Flexiva Pulse 242 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 : M006L8405910
Why the product was 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
Distribution information
Worldwide distribution - US Nationwide and the country of Canada.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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