Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a… — Class II medical device recall Z-2735-2018
Terminated recall by Boston Scientific Corporation, reported 2018-08-15, distributed nationwide. Potential polymer material degradation.
| Recall number | Z-2735-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2017-12-11 |
| Classified | 2018-08-08 |
| Reported by FDA | 2018-08-15 |
| Terminated | 2019-11-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 31,005 |
| Reason classes | specification failure |
| Lot numbers | 17987235, 17996381, 17996382, 17996711, 17997088, 18052298, 18052402, 18052417, 18052566, 18055179, 18056237, 18056695, 18056772, 18070824, 18070877, 18071646, 18072249, 18072272, 18080732, 18081509, 18082040, 18082155, 18082209, 18082547, 18082548, 18090719, 18091068, 18091155, 18091555, 18091855, 18092061, 18092066, 18097752, 18098344, 18098359, 18101964, 18102263, 18102586, 18106676, 18107079 and 460 more |
Product
Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with a polymer liner on the inside diameter for lubricity, stainless steel wire reinforcement within the wall for torque transmission and strength, and polymer materials along the length of the catheter for support and flexibility. The catheter has an atraumatic tip and a hub/strain relief combination for kink resistance (at the hub), device connectivity, and device handling.
Reason for recall
Potential polymer material degradation.
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-2735-2018. 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.