FDA-Device2026-07-08Class II
CRE Wireguided 18-20mm 240cm
Hazard
Potential sterile breach of the pouches in which devices are packaged.
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 Wireguided 18-20mm 240cm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2637-2026More Boston Scientific Corporation recalls
- FDA-Device2026-07-08CRE Pro Wireguided 12-15mm 240cm
- FDA-Device2026-07-08CRE Pro Wireguided 10-12mm 240cm
- FDA-Device2026-07-08CRE Pro Wireguided 15-18mm 240cm
- FDA-Device2026-07-08CRE Pro Wireguided 6-8mm 240cm
- FDA-Device2026-07-08CRE Wireguided 8-10mm 240cm
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