# FDA recall Z-2673-2017

> **Boston Scientific Corporation** · Class II · device recall initiated 2017-06-01.

## Product

Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter  9-12mm Above  UPN: M00547300

## Reason for recall

Label on the affected devices incorrectly identifies the   injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon

## Distribution

MI, MO  Foreign:  Austria  France  Great Britain  Italy  Spain  Sweden

## Key facts

- **Recall number:** Z-2673-2017
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-01
- **Report date:** 2017-07-12
- **Termination date:** 2018-06-26

- **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-2673-2017

## Citation

> AI Analytics. FDA recall Z-2673-2017. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2673-2017. Source: US FDA. Licensed CC0.

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