FDA-Device2026-07-08Class IIPACKAGING DEFECT
Boston Scientific CRE Wireguided catheters recalled for potential sterile breach
What this means
Boston Scientific has recalled certain CRE Wireguided 12-15mm catheters (model M00558480) due to a potential sterile breach in the device packaging pouches. The affected devices were distributed worldwide, including in the United States. No injuries have been reported.
- Check if you have one of the affected lots (38033567 through 38944841, expiring October 2028–February 2029).
- Contact Boston Scientific or your supplier for instructions on device return or replacement.
- Do not use affected devices if a sterile breach is suspected or packaging appears 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 Wireguided 12-15mm 240cm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2635-2026More Boston Scientific recalls
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