FDA-Device2026-07-08Class IIPACKAGING DEFECT
Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile packaging breach
What this means
Boston Scientific identified a potential sterile breach in the packaging of certain CRE Pro Wireguided 6-8mm 240cm catheters. The devices may have been exposed to contamination during packaging. No injuries have been reported.
- Check your device lot number against the list provided by Boston Scientific.
- Contact Boston Scientific or your healthcare facility for instructions on device handling or replacement.
- Do not use affected devices if sterility is in question.
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 6-8mm 240cm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2626-2026More Boston Scientific recalls
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