Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-340QRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07445161012180), received between Nov 8, 2024 and May 11, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Device Appears to Trigger Rejection

  TAIWAN. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2023 REQUIRED A REVISION SURGERY DUE TO A BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE. NO PATIENT DEMOGRAPHICS, SUCH AS WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Capsular Contracture

  MAUDE report 25139232 ↗
• InjuryDec 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ARGENTINA. ALLEGEDLY, THE PATIENT UNDERWENT IMPLANT REPLACEMENT SURGERY IN (B)(6) 2025, BY (B)(6) 2025, SHE PRESENTED WITH BILATERAL CAPSULAR CONTRACTURE CONSISTENT WITH HER SYMPTOMS (SN: (B)(6)). NO PATIENT DEMOGRAPHICS, SUCH AS WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Capsular Contracture

  MAUDE report 23771637 ↗
• InjuryDec 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ARGENTINA. ALLEGEDLY, THE PATIENT UNDERWENT IMPLANT REPLACEMENT SURGERY IN (B)(6) 2025, BY (B)(6) 2025, SHE PRESENTED WITH BILATERAL CAPSULAR CONTRACTURE CONSISTENT WITH HER SYMPTOMS (SN: (B)(6)). NO PATIENT DEMOGRAPHICS, SUCH AS WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Capsular Contracture

  MAUDE report 23771611 ↗
• InjurySep 18, 2025Break; Break

  AUSTRALIA. IT WAS REPORTED THAT A PATIENT WHO HAD AUGMENTATION SURGERY WITH IMPLANTS ON (B)(6) 2022, WAS DIAGNOSED WITH AN IMPLANT RUPTURE AND LYMPHADENOPATHY IN HER LEFT BREAST. REVISION SURGERY IS SCHEDULED FOR ON (B)(6) 2025. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 23085561 ↗
• InjuryAug 4, 2025Break; Break

  AUSTRALIA. IT WAS REPORTED THAT A PATIENT WHO HAD AUGMENTATION SURGERY WITH IMPLANTS IN (B)(6) 2020 HAD A REVISION SURGERY DUE TO A DEVICE RUPTURE IN HER LEFT BREAST (SN (B)(6)). NO PATIENT DEMOGRAPHICS, SUCH AS WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700736 ↗
• InjuryJul 28, 2025Break; Break

  AUSTRALIA. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AUGMENTATION SURGERY IN (B)(6) 2020, UNDERWENT A REVISION SURGERY TO REDUCE THE SIZE IMPLANT AND REPLACE THEM. AS AN INCIDENTAL FINDING, THE SURGEON NOTED THAT THE RIGHT BREAST IMPLANT WAS RUPTURED. NO PATIENT DEMOGRAPHICS, SUCH AS WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637754 ↗
• InjuryMar 14, 2025Break; Break

  REPORT UPDATE ¿ THE SERIAL NUMBER OF THE AFFECTED IMPLANT HAS BEEN UPDATED BASED ON NEWLY RECEIVED INFORMATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610369 ↗
• InjuryNov 21, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT DURING A REVIEW LAST WEEK, THE PATIENT PRESENTED WITH LEFT-SIDED CAPSULAR CONTRACTURE, CAUSING PAIN AND NOTICEABLE ASYMMETRY. THE PATIENT WAS REFERRED FOR AN ULTRASOUND TO CONFIRM THE DIAGNOSIS, AND A CAPSULECTOMY WITH IMPLANT REPLACEMENT ON THE LEFT SIDE WAS DISCUSSED.

  Patient problems: Breast Discomfort/Pain; Capsular Contracture

  MAUDE report 20750990 ↗
• InjuryNov 8, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH GRADE IV CAPSULAR CONTRACTURE ON THE RIGHT SIDE. PHOTOGRAPHS AND OPERATION NOTES HAVE BEEN PROVIDED FOR REFERENCE. THE PATIENT IS EXPERIENCING PAIN AND DISCOMFORT, WITH A NOTABLE FIRMNESS IN THE RIGHT BREAST, AS OBSERVED IN THE ATTACHED PHOTOS.

  Patient problems: Capsular Contracture

  MAUDE report 20645516 ↗