FDA-Device2026-07-08Class IIPACKAGING DEFECT
Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
What this means
Boston Scientific has recalled CRE Pro Wireguided catheters (15–18mm, 240cm) because some packaging pouches may have a sterile breach. This affects specific lot numbers distributed worldwide. No injuries have been reported.
- Check your device lot number against the FDA recall notice.
- Contact Boston Scientific or your healthcare facility if you have an affected device.
- Do not use affected devices; consult your physician for guidance on replacement or procedure timing.
The agency's original wording
Hazard
Potential sterile breach of the pouches in which devices are packaged.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
81,543 units
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
CRE Pro Wireguided 15-18mm 240cm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2630-2026More Boston Scientific recalls
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