FDA-Device2026-07-08Class IIPACKAGING DEFECT
Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
What this means
Boston Scientific Corporation is recalling certain CRE Pro Wireguided catheters (18–20 mm, 240 cm) due to a potential sterile breach in the packaging pouches. The breach could compromise the sterility of the devices before use. This affects approximately 81,543 units distributed worldwide.
- Check if you have CRE Pro Wireguided 18–20 mm catheters with lot numbers between 38031485 and 38964093 and expiration dates between November 23, 2028, and March 29, 2029.
- Do not use affected devices if the pouch shows visible damage or signs of tampering.
- Contact your supplier or Boston Scientific for instructions on returning or replacing affected units.
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 18-20mm 240cm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2631-2026More Boston Scientific recalls
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