Gentrix® MSPL0507Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00386190001226), received between May 31, 2019 and Jan 2, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 12/6/19, ACELL, INC. BECAME AWARE THAT AN ACELL DEVICE WAS EXPLANTED DUE TO A BOWEL OBSTRUCTION. THE ACELL DEVICE WAS IMPLANTED (B)(6) 2019 AND EXPLANTED ON (B)(6) 2019. WE ARE SUBMITTING THIS REPORT NOW, HOWEVER, ADDITIONAL INFORMATION HAS BEEN REQUESTED. AN UPDATE "WLLL" BE PROVIDED UPON RECIEPT OF MORE INFORMATION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 9538229 ↗
• MalfunctionMay 31, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(4) 2019, ACELL, INC. BECAME AWARE THAT SUTURE PULL THROUGH OCCURRED WITH AN ACELL DEVICE DURING THE REINFORCEMENT OF A UMBILICAL 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 8659456 ↗