FDA-Device2026-07-08Class IIPACKAGING DEFECT
Boston Scientific CRE Pro Wireguided catheters recalled for sterile packaging breach risk
What this means
Boston Scientific has recalled certain CRE Pro Wireguided catheters (8–10 mm, 240 cm) because the sterile pouches protecting these devices may have been breached during manufacturing or packaging. A breached sterile barrier could allow bacteria or other contamination to reach the device before use. The recall affects 81,543 units distributed worldwide.
- Check if you have CRE Pro Wireguided catheters with lot numbers matching the recall list (lot numbers 38031497 through 38960099, with expiration dates November 23, 2028 – March 30, 2029).
- Do not use affected devices.
- Contact Boston Scientific or your healthcare provider for guidance on replacement or alternative devices.
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 8-10mm 240cm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2627-2026More Boston Scientific recalls
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