Vertessa Lite Y-Mesh 26x4x3cm CAL-VLY2643Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00890594000483), received between Apr 10, 2018 and Nov 6, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2025Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE EXPIRATION DATE DISPLAYED ON THE VLY2643 PACKAGING IS NOT THE REAL DATE. THE IMPLANT SHOWS IT EXPIRES ON FEBRUARY 29TH, 2029.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493198 ↗
• MalfunctionJul 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. (B)(6) MENTIONED THAT SHE "HAD A COUPLE OF FAILURES OF VERTESSA LITE" WHICH OCCURRED BY A "COMPLETE PULL THROUGH AT THE SACRUM." SHE MENTIONED THAT THEY HAPPENED "RECENTLY" HOWEVER, DID NOT CLARIFY WHEN THEY HAD OCCURRED AND WHEN THE PATIENTS HAD THEIR FIRST SURGERY. NO PRODUCT WAS RETURNED AND NO ADDITIONAL INFORMATION WAS COMMUNICATED.

  Patient problems: Insufficient Information

  MAUDE report 22560070 ↗
• InjuryFeb 24, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DR. (B)(6) CORRECTED A FAILED SACROCOLPOPEXY ORIGINALLY DONE BY A DIFFERENT SURGEON WITH VERTESSA LITE. HE STATED THAT IN HIS CONVERSATION WITH THE PATIENT, THAT THE FAILURE OCCURED ABOUT ONE WEEK POST-OP. PER DR. (B)(6), PRODUCT WAS TENSIONED TOO TIGHT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21450378 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON REPORTED THAT AT PATIENTS FOLLOW-UP VISIT, SHE PRESENTED WITH LUMBAR OSTEOMYELITIS.

  Patient problems: Osteomyelitis

  MAUDE report 20855079 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON REPORTED THAT PATIENT PRESENTED WITH FEVER AT FOLLOW-UP VISIT.

  Patient problems: Fever

  MAUDE report 20854854 ↗
• InjuryJun 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  SALES REP REPORTED VIA EMAIL THAT A PHYSICIAN MENTIONED AN ADVERSE OUTCOME ON (B)(6) 2018 FROM VERTESSA LITE AND DESARA BLUE TV. "THE PATIENT HAD AN EROSION AND EXTRUSION." ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM SURGEON INCLUDING DETAILS, TREATMENT, AND LOT NUMBERS ASSOCIATED WITH EACH ISSUE. DR. RESPONDED WITH ADDITIONAL INFORMATION: "I CAN TRY TO ASK IN OPERATION ROOM IF THEY CAN LOOK UP LOT NUMBER, I FOUND SOME INFO IN EPIC. DATE OF SURGERY (B)(6) 2018. MIDURETHRAL MESH EXPOSURE, MIDLINE AND TO THE RIGHT SIDE. USING ESTROGEN CREAM BEFORE AND AFTER SURGERY. TREATED WITH ESTROGEN, BUT VERY TENDER AND COULD NOT TOLERATE OFFICE TRIM FOR MESH REMOVAL. ON (B)(6) 2018 SLING EXCISION AND CYSTOSCOPY PLANNED. I WILL LET YOU KNOW IF ANYTHING UNUSUAL." LATER SALES REP PROVIDED ADDITIONAL INFORMATION: "I EMAILED DR. KANE LAST NIGHT ASKING FOR CLARIFICATION ON THE VL EROSION. SHE MENTIONED THAT TO ME LAST WEEK WHEN I SAW HER BUT DIDN'T MENTION IT IN THE EMAIL SHE SENT YESTERDAY. SHE TOLD ME THE VL WAS ERODING AT THE APEX OF THE PATIENT'S VAGINA. SHE MENTIONED THE DESARA WAS CAUSING MORE OF A DISCOMFORT FOR THE PATIENT'S HUSBAND DURING INTERCOURSE BUT LED ME TO BELIEVE IT WAS EXTRUDING

  Patient problems: Erosion

  MAUDE report 8724989 ↗
• MalfunctionApr 10, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT UNDERWENT HER FIRST SURGERY FOR LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY, REMOVAL OF BOTH TUBES AND OVARIES, LAPAROSCOPIC SACROLPOPEXY, ANTERIOR AND POSTERIOR REPAIR, AND CYSTOSCOPY. PATIENT WAS ADMITTED FIVE DAYS LATER WITH NAUSEA AND ABDOMINAL PAIN. SUBSEQUENTLY, NINE DAYS LATER THE PATIENT UNDERWENT SURGERY FOR DIAGNOSTIC LAPAROSCOPY, LYSIS OF ADHESION, OPEN LAPAROTOMY, AND PARTIAL SMALL BOWEL RESECTION WITH ANASTOMOSIS. THE Y-MESH WAS ADHERING TO THE BOWEL IN RIGHT LOWER QUADRANT OF ABDOMEN. UF/IMPORTER REPORT # (B)(4).

  Patient problems: Pain

  MAUDE report 7419882 ↗