Guider Softip XF — Class II medical device recall Z-0334-2017
Terminated recall by Stryker Neurovascular, reported 2016-11-09, distributed in AK, IL, OH. Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that
| Recall number | Z-0334-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Neurovascular, Fremont, CA, United States |
| Recall initiated | 2016-10-05 |
| Classified | 2016-11-02 |
| Reported by FDA | 2016-11-09 |
| Terminated | 2017-03-23 |
| Distributed | AK, IL, OH |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CL, CZ, DE, EC, EG, ES, FR, GB, GR, HU, IL, IN, IR, JP, KR, MX, NL, NO, PE, PH, PL, RS, RU, SE, SG, SK, TH, TN, TR, UY, VN, ZA |
| Quantity | 1,478 devices |
| Reason classes | packaging |
| Lot numbers | 18713574, 18848795, 18849984 |
| Model numbers | M003101480 |
| Expiration dates | 2018-11-30, 2019-01-31 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0334-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.