—#186810

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

FDA product code: KOH — Instrument, Manual, General Obstetric-Gynecologic
Device class: Class 1
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: All unexpired lots: C003699 C003715 C003735 C003750 C003775 C003804 C003813 C003842 C003853 C003887 C003905 C003936 C003950 C003960 C003966 C003986 C003997 C004028 C004041 C004078 C004091 C004107 C004117 C004128 C004136 C004160 C004186 C004206 C004221 GTIN 08714729848097

Why it was recalled

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

Root cause (FDA determination)

Packaging process control

Action the firm took

Boston Scientific issued Urgent Medical Device Product Removal on 4/15/21 via FedX. Letter states reason for recall, health risk and action to take; Individually packaged Upsylon Y Mesh (UPN M0068318200) is not impacted by this removal. This removal affects only the UPNs and batches listed below and in Attachment 1. No other UPNs or batches are impacted by this removal. Please cease further distribution or use of any remaining product affected by this removal immediately. If you identify any product from the affected lots/batches within your inventory, please segregate the product immediately and return it to BSC in accordance with the enclosed instructions and indicate on your Reply Verification Tracking Form the quantity of units from each lot/batch that you will be returning. BSC is notifying regulatory authorities of this removal as required. Please read carefully through the removal instructions included with this notification. Your local Sales Representative can answer any questions that you may have regarding this notification.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2021-04-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186810. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.