Class II — Stryker Neurovascular
| Recalling firm | STRYKER CORP. |
|---|---|
| Registered facility | View this company's 61 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product. |
| Product | Guider Softip XF; GUIDER/MP XF/8FR/100 cm, Model number: M003101480. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system. |
| Quantity | 1478 devices total, all model numbers and lots. |
| Distribution | Worldwide Distribution - US including AK, IL, OH and Internationally to: ARGENTINA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHILE CZECH REPUBLIC ECUADOR EGYPT FRANCE GERMANY GREECE HUNGARY INDIA IRAN ISRAEL ITALIA JAPAN MEXICO NETHERLANDS NORWAY PERU PHILIPPINES POLAND RUSSIA SERBIA SINGAPORE SLOVAKIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND THAILAND TUN… |
| Initiated | 2016-10-05 |
| Classified | 2016-11-02 |
| Terminated | 2017-03-23 |
| Recall number | Z-0334-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Stryker Neurovascular (Z-0334-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75447/
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