Natrelle INSPIRA Breast Implants TRX-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10888628008502), received between Nov 13, 2019 and Sep 28, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (5 reports).

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

3 other recalls cover devices cleared under the same FDA submission (P020056); they may or may not involve this specific model.

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.

Recalls naming this device

1. Jul 24, 2019Class IOpen, Classified

   The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

   Z-2453-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient reported through a Company Representative ''Sudden swelling", "Hardness", "Pain" and "Recall". This record is for the left side. Device remains implanted.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Discomfort/Pain; Swelling/ Edema

  MAUDE report 50914707 ↗
• InjurySep 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED "¿HEALTH HAS DECLINED OVER THE LAST FEW YEARS WITH IMMUNE PROBLEMS - NOT DEVICE RELATED, UNDERACTIVE THYROID - NOT DEVICE RELATED, LOW IMMUNE SYSTEM - NOT DEVICE RELATED, RHEUMATOID ARTHRITIS - NOT DEVICE RELATED, SWOLLEN GLANDS, LUMPS IN ARMPITS, PERMANENTLY EXHAUSTED - NOT DEVICE RELATED, CONCERNS REGARDING BII AND ALCL. PATIENT IS SEEING A NEUROPSYCHOLOGIST - NO ANSWERS FROM TESTS AND HAS BEEN SIGNED OFF WORK FOR A LONG TIME. PATIENT REPORTED LUMPS IN THE LEFT... ONE BREAST IS COMPLETELY HARD, THE SHAPE HAS CHANGED¿¿ DEVICE REMAINS IMPLANTED. THIS RECORD RELATES TO THE LEFT SIDE.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 17769786 ↗
• InjuryFeb 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16368362 ↗
• InjuryOct 1, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURED DEVICE." THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12563242 ↗
• InjuryDec 4, 2020Material Rupture; Material Rupture

  PATIENT REPORTED VIA REGULATORY AGENCY THAT THE "IMPLANT RUPTURED." DEVICE HAS BEEN EXPLANTED. AFFECTED SIDE IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 10943828 ↗
• InjuryOct 2, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED LEFT SIDE "JOINT INFLAMMATION IN THE KNEES", UNRELATED TO THE DEVICE, "SCAR TISSUE, PAIN¿ AND ¿BURNING SENSATION.¿ HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10620662 ↗
• InjuryAug 26, 2020Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  PATIENT REPORTED UNKNOWN SIDE " HAS TEXTURED IMPLANTS" AND "CAPSULAR CONTRACTURE, OR A RUPTURE." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10456754 ↗
• InjuryFeb 27, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9763863 ↗
• InjuryJan 16, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. PATIENT ADDITIONALLY REPORTED ""PROBLEMS WITH MY HANDS AND ARMS", "SWELLING", "REDNESS", "PALLOR", "CHANGE IN TEMPERATURE", "SEVERE PAIN", "SEVERE PAIN IN NECK", "EXTREME VASCULAR AND NEURO PROBLEMS IN MY UPPER EXTREMITIES", "UNABLE TO USE MY HANDS", "SEVERAL ACUTE BILATERAL POSTERIOR RIB FRACTURES WITHOUT TRAUMA OR INCIDENT", "RIB FRACTURES" AND "DEVELOPED SEVERE RIB PAIN." THESE EVENTS ARE NOT DEVICE RELATED. PATIENT ALSO REPORTED "DEVELOPED SEVERE BACK AND CHEST PAIN." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9597698 ↗
• InjuryJan 13, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED. .

  Patient problems: Capsular Contracture

  MAUDE report 9581698 ↗
• InjuryNov 13, 2019Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE I, AND RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9316044 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020056. One submission often covers many models, so check the product and lot details in each record.

• Z-0700-2020 · Nov 6, 2019 · Terminated
  Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod
• Z-0701-2020 · Nov 6, 2019 · Terminated
  Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 762
• Z-2454-2019 · Jul 24, 2019 · Open, Classified
  Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-