Gentrix® PSMT2030Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00386190001561), received between Oct 17, 2018 and Apr 27, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 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. How this data works · Data updated Oct 13, 2026.

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.

• MalfunctionApr 27, 2022Material Fragmentation; Material Fragmentation

  A FACILITY REPORTED A GENTRIX SURGICAL MATRIX RIPPED DURING SUTURE IN MULTIPLE PLACES. THE MATRIX WAS USED FOR AN ABDOMINAL WALL RECONSTRUCTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219760 ↗
• MalfunctionDec 20, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ON"11/2119," ACELL, INC. BECAME AWARE THAT SUTURE PULL THROUGH OCCURRED WITH AN ACELL DEVICE DURING AN INCISIONAL HERNIA REPAIR. THE DEVICE WAS NOT USED. THE SURGEON DECIDED TO USE AN UNKNOWN, NON-ACELL DEVICE WHICH RESULTED IN A SURGICAL DELAY (INCREASED SURGERY TIME). THE PATIENT DID NOT EXPERIENCE ANY COMPLICATION DUE TO THE SUTURE PULL THROUGH NOR THE INCREASED SURGERY TIME.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9500492 ↗
• MalfunctionJul 27, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2019, ACELL, INC. BECAME AWARE THAT SUTURE PULL THROUGH OCCURRED WITH AN ACELL DEVICE DURING THE REINFORCEMENT OF A VENTRAL HERNIA REPAIR. THE DEVICE WAS NOT USED. THE SURGEON DECIDED TO CLOSE THE HERNIA PRIMARILY WHICH RESULTED IN A SURGICAL DELAY (INCREASED SURGERY TIME). THE PATIENT DID NOT EXPERIENCE ANY COMPLICATION DUE TO THE SUTURE PULL THROUGH NOR THE INCREASED SURGERY TIME.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8834607 ↗
• InjuryOct 17, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2018, ACELL, INC. BECAME AWARE THAT SUTURE PULL THROUGH OCCURRED WITH AN ACELL DEVICE DURING THE REINFORCEMENT OF A VENTRAL HERNIA REPAIR. THE DEVICE WAS NOT USED. THE SURGEON REQUESTED AND USED A DEVICE FROM A DIFFERENT MANUFACTURER WHICH RESULTED IN A SURGICAL DELAY (INCREASED SURGERY TIME). THE PATIENT DID NOT EXPERIENCE ANY COMPLICATION DUE TO THE SUTURE PULL THROUGH NOR THE INCREASED SURGERY TIME.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7975181 ↗