FDA-Device2022-03-23Class II
JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250
Hazard
Sterility of device is compromised due to a sterile barrier breach
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.
Affected count
68 units
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0766-2022More Boston Scientific Corporation recalls
- FDA-Device2026-07-08CRE Pro Wireguided 12-15mm 240cm
- FDA-Device2026-07-08CRE Pro Wireguided 10-12mm 240cm
- FDA-Device2026-07-08CRE Pro Wireguided 15-18mm 240cm
- FDA-Device2026-07-08CRE Pro Wireguided 6-8mm 240cm
- FDA-Device2026-07-08CRE Wireguided 8-10mm 240cm
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