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Open, Classified

CRE Wireguided 10-12mm 240cm

FDA Recall Z-2634-2026 · Posted 2026-07-01

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeFDT
Date Initiated2026-05-21
Product Quantity81,543 units

Reason for Recall

Potential sterile breach of the pouches in which devices are packaged.

Firm Action

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

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tobago, Trinidad, Tunisia, T¿rkiye, United Arab Emirates, Uruguay.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110833CRE BALLOON DILATATION CATHETERBoston Scientific Corporation · 2011-04-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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