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Class II recall Z-0258-2027: Boston Scientific Cork, Ltd.
Class II recall Z-0258-2027: Boston Scientific Cork, Ltd.: Boston Scientific Cork, Ltd. Dated 7 days ago, it is inside the fresh trigger window. Score 68/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 499 related FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0258-2027 |
| Recalling firm | Boston Scientific Cork, Ltd. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195750 |
| Reason | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Quantity | 432 |
| Distribution | Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Jap |
| Recall initiated | 2026-09-16 |
| Reported | 2026-10-28 |
| Firm location | Cork, Ireland |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-28
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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68 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 7 days ago.
What is the FDAPulse record for Class II recall Z-0258-2027: Boston Scientific Cork, Ltd.?
Class II device recall Z-0258-2027 by Boston Scientific Cork, Ltd.: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface
How does Class II recall Z-0258-2027: Boston Scientific Cork, Ltd. compare to other FDAPulse records?
It is fresh: dated 7 days ago, inside the window where early outreach matters most.
Class II recall Z-0258-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-0258-2027 | 2026-10-28 | |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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