FDA Device recall Z-1490-2021
Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and m…
- FDA Device
- Class II
- ongoing
- Published 2021-05-05
On 2021-05-05 the FDA classified a Class II recall of Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and m… by Boston Scientific, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1490-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-04-15 |
| Published | 2021-05-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | US |
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
Reason
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
Identifiers
| code_info | All unexpired lots: C003699 C003715 C003735 C003750 C003775 C003804 C003813 C003842 C003853 C003887 C003905…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1490-2021%22
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