FDA-Device2026-07-08Class IIPACKAGING DEFECT
Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
What this means
Boston Scientific recalled certain CRE Pro Wireguided catheters (12–15 mm, 240 cm) due to a potential breach of the sterile packaging pouches. Affected units were distributed worldwide and have expiration dates between November 2028 and March 2029. The company has not reported any injuries related to this issue.
- Check if you have any affected CRE Pro Wireguided catheters by matching the lot numbers listed in the recall notice.
- Contact Boston Scientific or your healthcare provider if you have stock of these devices.
- Do not use affected devices if the pouch integrity is compromised.
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 12-15mm 240cm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2629-2026More Boston Scientific recalls
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