FDA-Device2026-07-08Class IIPACKAGING DEFECT
Boston Scientific CRE Wireguided catheter recalled for potential sterile pouch breach
What this means
Boston Scientific has recalled certain CRE Wireguided catheters (10-12mm, 240cm) due to a potential breach in the sterile packaging pouches. The affected devices were distributed worldwide. No injuries have been reported.
- Check if you have an affected lot number (38099718, 38165001, 38165002, or others through 38871163) with expiration date between November 2, 2028 and February 23, 2029.
- Contact Boston Scientific or your supplier if you have affected units.
- Do not use affected devices until you confirm they are not on the recall list.
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 Wireguided 10-12mm 240cm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2634-2026More Boston Scientific recalls
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