FDA Device recall Z-0340-2017
Guider Softip XF
- FDA Device
- Class II
- terminated
- Published 2016-11-09
On 2016-11-09 the FDA classified a Class II recall of Guider Softip XF by Stryker Neurovascular, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0340-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-05 |
| Published | 2016-11-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Neurovascular |
| Distribution | AK, IL, OH |
Product
Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
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.
Identifiers
| code_info | Lot s 18771332, 18771915; Expiration 12/31/18. Lot s18903165, 18928715; Expiration 01/31/2019. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0340-2017%22
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