Colpassist M0068318210Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729848097), received between Jun 13, 2017 and Jan 14, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Apr 15, 2021Open, Classified

   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

   Z-1490-2021 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COLPASSIST Y-MESH WAS IMPLANTED INTO THE PATIENT FOR THE TREATMENT OF PROLAPSE DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, SACROCOLPOPEXY AND ABDOMINAL PERINEAL REPAIR PROCEDURE PERFORMED ON (B)(6) 2017. AS REPORTED BY THE PATIENT ATTORNEY, ON (B)(6) 2018, THE PATIENT IS STILL EXPERIENCING URINARY URGE INCONTINENCE. ON (B)(6) 2018, HER MAIN CONCERN WAS POST VOID LEAKAGE AND A SMALL MESH EXPOSURE WAS OBSERVED. ON (B)(6) 2018, SHE IS STILL EXPERIENCING URINARY URGENCY AND HAD UTI (URINARY TRACT INFECTION) WHICH WAS TREATED WITH ANTIBIOTICS. ON (B)(6) 2019, MESH EXPOSURE IN VAGINA WAS NOTED. EXCISON OF MESH EXPOSURE IN THE VAGINA UNDER GENERAL ANESTHESIA WAS RECOMMENDED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE.

  Patient problems: Erosion; Incontinence; Micturition Urgency; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 11175560 ↗
• MalfunctionJun 13, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COLPASSIST¿ WAS TO BE USED DURING A MID-URETHRAL SLING PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THERE WAS A BLACK FOREIGN MATTER WITH THE DEVICE INSIDE THE PACKAGE. THE DEVICE WAS NOT USED ON A PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER COLPASSIST¿. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6639251 ↗