Home / Recalls / Boston Scientific Corporation / Z-1490-2021

Z-1490-2021 Class II Ongoing

Recalled by Boston Scientific Corporation — Marlborough, MA

FDA device recall Z-1490-2021 was initiated by Boston Scientific Corporation on April 15, 2021 and is designated Class II. Reason for recall: 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 The recall status is ongoing. Affected quantity: 4,549 WW.

Recall Details

Product Type
Devices
Report Date
May 5, 2021
Initiation Date
April 15, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,549 WW

Product Description

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 for Recall

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

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.

Code Information

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

Other recalls by Boston Scientific Corporation

  • Z-2725-2026 Class II — Rapid Refill Continuous Injection System, UPN M00566001 (June 30, 2026)
  • Z-2839-2026 Class II — Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and U (June 30, 2026)
  • Z-2838-2026 Class II — Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions an (June 30, 2026)
  • Z-2840-2026 Class II — Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: (June 30, 2026)
  • Z-2771-2026 Class II — Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M001395 (June 19, 2026)
  • Z-2752-2026 Class II — FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation (June 11, 2026)
  • Z-2750-2026 Class II — FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M4 (June 11, 2026)
  • Z-2755-2026 Class II — FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature a (June 11, 2026)
  • Z-2753-2026 Class II — FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M4 (June 11, 2026)
  • Z-2754-2026 Class II — FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculatu (June 11, 2026)

FDA data resources