FDA-Device2022-03-23Class II
HYDRATOME RX 44-30MM/450CM Material Number: M00583070
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
251 units
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
HYDRATOME RX 44-30MM/450CM Material Number: M00583070
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0762-2022More 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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