CRE Pro Wireguided 10-12mm 240cm
FDA device recall Z-2628-2026 · posted 2026-07-01 · Open, Classified
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Potential sterile breach of the pouches in which devices are packaged.
- Action taken
- An Urgent Medical Device Removal - Immediate Action Required notification was mailed to consignees on 5/21/26. This notification informed consignees that Boston Scientific was conducting a removal of affected devices due to a potential sterile breach of product packaging (pouches). Consignees are instructed to immediately stop further use or distribution of product and quarantine them. Consignees are to complete and return the provided Reply Verification Tracking Form and return the product to Boston Scientific per the provided instructions. Consignees are to share the recall notification with any healthcare provider that uses the affected devices and with organizations to which product was further distributed. Consignees with any questions are to contact their Boston Scientific representative.
- Root cause
- Package design/selection
- Status
- Open, Classified
- Product code
- FGE
- Quantity affected
- 81,543 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Re
- Date initiated
- 2026-05-21
- Date posted
- 2026-07-01
- Location
- Marlborough, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CRE DITATATION BALLON (K112994) | Boston Scientific Corporation | 2012-02-10 |