Entuit G35569Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002355699), received between Apr 15, 2016 and Jun 22, 2017 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Separation” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING GASTROPEXY USING A ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET. THE CUSTOMER REPORTS THAT THE WIRE BREAKS BEFORE THEY CAN SQUEEZE THE ANCHOR ON THE SKIN. THE PHYSICIAN OBTAINED A REPLACEMENT DEVICE AND COMPLETED THE PROCEDURE THROUGH ANOTHER PUNCTURE SITE. THE DEVICE THAT IS THE SUBJECT OF THIS REPORT IS NOT AVAILABLE FOR EVALUATION. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6659904 ↗
• InjuryMay 19, 2016Material Separation; Material Separation

  WHILE CONDUCTING A GASTROPEXY, WHEN PLACING THE ANCHOR, THE WIRE BROKE. THE SAME HAPPENED WITH 2 SUCCESSIVE KITS OF THE SAME LOT NUMBER. THE WIRES AND ANCHORS COULD NOT BE KEPT AS THEY FELL INTO THE STOMACH AND WERE WASHED AWAY IN THE DIGESTIVE TRACT. THE USER FACILITY WAS ABLE TO SUCCESSFULLY COMPLETE THE GASTROPEXY WITH THE 3RD KIT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 5667154 ↗
• InjuryApr 15, 2016Material Separation; Material Separation

  DURING THE PLACING OF A GASTROSTOMY TUBE, THE DOCTOR HAD TO PLACE ANCHORS IN ORDER TO ATTACH THE STOMACH WALL TO THE ABDOMINAL WALL. AFTER THE ANCHOR INSERTION, THE RADIOLOGIST PULLED THE SUTURE FOR APPROACH TO THE STOMACH FROM THE ABDOMINAL WALL, BUT THE SUTURE BROKE. THERE WERE NO CONSEQUENCES FOR THE PATIENT BECAUSE THE ANCHORS FOLLOWED THE DIGESTIVE PATH ONCE RELEASED. THERE WAS A SIGNIFICANT LOSS OF TIME FOR THE OPERATOR AND THE OPERATOR HAD TO USE ANOTHER ANCHOR SET TO CONTINUE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5581468 ↗