Gentrix® PSMX0710 (UDI 00386190001370)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00386190001370), received between Feb 13, 2019 and Feb 13, 2019 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 1/15/19, ACELL, INC. WAS NOTIFIED BY A PHYSICIAN THAT THEIR PATIENT WAS COMPLAINING OF HAVING DIFFICULTY SWALLOWING 9 WEEKS POST-OPERATIVE. THE SURGEON CONDUCTED A GASTRIC BYPASS AND HIATAL HERNIA REPAIR WITH AN ACELL DEVICE ON (B)(6) 2018. THE PATIENT PRESENTED WITH THE SYMPTOMS AT THE ER 9 WEEKS POST-OPERATIVE; AN INDEX CT SCAN WAS CONDUCTED WHICH SHOWED SOME NARROWING. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR 2 DAYS. A UGI SERIES AND AN EGD WITH EUS WERE PERFORMED. THE RESULTS INDICATED THE DISTAL ESOPHAGUS WAS PATENT WITH NO OBSTRUCTION AND THE EUS REVEALED NO SIGNIFICANT FLUID PRESENT. THE PATIENT DID NOT REQUIRE INTERVENTION FOR THE DYSPHAGIA AND IS NOW ASYMPTOMATIC. THE SURGEON CANNOT CONFIRM THAT THE ACELL DEVICE WAS RELATED TO THE SYMPTOMS THE PATIENT REPORTED AND IS SATISFIED WITH THE OUTCOME OF THE PATIENT. THE DEVICE WAS NOT EXPLANTED.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 8335351 ↗