FDA-Device2021-05-05Class II
Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210
Hazard
Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
Sold states
Worldwide distribution - US Nationwide distribution and the countries of Algeria, Brazil, Colombia, Estonia, Germany, Hong Kong, Australia, Canada, Costa Rica, Finland, Great Britain, Italy, Austria, Chile, Czech Republic, France, Greece, Jordan, Belgium, Lebanon, Mauritius, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan.
Affected count
4,549 WW
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1490-2021More Boston Scientific Corporation recalls
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for sterile pouch breach risk
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile packaging breach
- FDA-Device2026-07-08CRE Wireguided 8-10mm 240cm
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