# FDA recall Z-0717-2020

> **Boston Scientific Corporation** · Class II · device recall initiated 2019-11-08.

## Product

AngioJet Ultra Consoles-Thrombectomy System   UPN:  105650-001D  105650-001H  105650-001R  105650-001Z  105650-002R  105650-004H  105650-004R  105650-007R  105650-009R  105650-024H  105650-024Z  105650-025  105650-025H  105650-025R  105650-026R    Product Usage - The AngioJet allows for percutaneous removal of thrombus located in peripheral arteries and veins, saphenous vein bypass grafts, native coronary arteries, and native or synthetic AV access conduits. Thrombectomy is accomplished using high-pressure saline jets contained in the catheter shaft. The saline jets create a low-pressure effect to draw thrombus into the catheter, fragment the thrombus, and remove the thrombus from the treatment site. The system consists of a single use Thrombectomy Set (several models available) and a free standing mobile Console.

## Reason for recall

Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.

## Distribution

Worldwide distribution - US Nationwide distribution and country of Canada.

## Key facts

- **Recall number:** Z-0717-2020
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-08
- **Report date:** 2019-12-25
- **Termination date:** 2021-03-24

- **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-0717-2020

## Citation

> AI Analytics. FDA recall Z-0717-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0717-2020. Source: US FDA. Licensed CC0.

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