# FDA recall Z-1392-2022

> **Boston Scientific Corporation** · Class III · device recall initiated 2022-05-31.

## Product

GreenLight HPSEA Laser Fibers, UPN 0010-2092

## 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.

## Key facts

- **Recall number:** Z-1392-2022
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-31
- **Report date:** 2022-07-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1392-2022

## Citation

> AI Analytics. FDA recall Z-1392-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1392-2022. Source: US FDA. Licensed CC0.

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