MENTOR CPX4 PLUS, Smooth, Tall Height SCPX140THRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10081317028458), received between May 10, 2022 and Aug 22, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Rupture” (4 reports).

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 18, 2026.

Recalls naming this device

1. Feb 18, 2026Class IIOpen, Classified

   Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

   Z-1684-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2025Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 650CC MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT ON BOTH SIDES AND EXPERIENCED BILATERAL EXPANDER DEFLATION. AS A RESULT, THE EXPANDERS WERE EXPLANTED ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22874423 ↗
• InjuryAug 22, 2025Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 650CC MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT ON BOTH SIDES AND EXPERIENCED BILATERAL EXPANDER DEFLATION. AS A RESULT, THE EXPANDERS WERE EXPLANTED ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22874409 ↗
• InjuryMay 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH AN UNSPECIFIED BREAST TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. IT WAS STATED THAT AFTER A MONTH, THE TISSUE EXPANDER WAS DEFECTIVE AND LEAKED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. IT WAS UNKNOWN IF THE REPORTED DEVICE WAS A MENTOR DEVICE AND AS SUCH THE COMPLAINT IS BEING REPORTED CONSERVATIVELY. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17032151 ↗
• InjuryMay 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CPX4 PLUS SMOOTH TALL HEIGHT 650CC BEING USED IN A BREAST SURGERY WAS FOUND TO BE DEFLATED DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14347929 ↗