Boston Scientific Corporation recalls Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in th

Recalled May 5, 2021 · FDA recall Z-1490-2021 · Boston Scientific

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 · FDA Class II

Units

4,549 WW

Sold at

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.

Description

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

Product

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

Manufacturer(s)

Boston Scientific Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →