# FDA recall Z-1133-2018

> **Boston Scientific Corporation** · Class II · device recall initiated 2017-12-20.

## Product

SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600

## Reason for recall

Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.

## Distribution

Worldwide Distribution US nationwide, Austria, Belarus, Belguim, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, Bahrain, China, Hong Kong, India, Malaysia, Pakistan, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Thailand, Tunisia, Turkey, Vietnam, Brazil, Canada, Cost Rica, Ecuador, Guatemala, Mexico, Peru

## Key facts

- **Recall number:** Z-1133-2018
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-20
- **Report date:** 2018-03-28
- **Termination date:** 2019-12-13

- **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-1133-2018

## Citation

> AI Analytics. FDA recall Z-1133-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-1133-2018. Source: US FDA. Licensed CC0.

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