FDA-Device2026-07-08Class IIPACKAGING DEFECT
Boston Scientific CRE Wireguided catheters recalled for potential sterile pouch breach
What this means
Boston Scientific Corporation is recalling CRE Wireguided 15-18mm 240cm catheters due to a potential sterile breach in the packaging pouches. The affected devices were distributed worldwide and may not maintain sterility if the pouch integrity is compromised. No injuries have been reported.
- Check if you have an affected device by matching the UPN (M00558490) and lot numbers listed in the recall notice.
- Do not use devices from affected lots.
- Contact Boston Scientific for instructions on device replacement or return.
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 15-18mm 240cm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2636-2026More Boston Scientific recalls
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