Entuit G35562Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002355620), received between Oct 31, 2014 and May 18, 2017 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

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 16, 2026.

Recalls naming this device

1. Mar 1, 2024Open, Classified

   Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

   Z-1529-2024 · 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.

• InjuryMay 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A CHAIT PERCUTANEOUS CECOSTOMY CATHETER WITH CECUM RETENTION ON AN UNSPECIFIED DATE. AN ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR WAS PLACED PERCUTANEOUSLY THROUGH THE ABDOMINAL WALL AND SET WITHIN THE PATIENT'S CAECUM. PLACEMENT OF THE CHAIT CECOSTOMY CATHETER WAS UNEVENTFUL. THE CUSTOMER REPORTED THAT THE ENTUIT SECURE GASTROINTESTINAL SUTURE "CHEESEWIRED" COMPLETELY THROUGH THE CAECUM AND CREATED A FISTULA TO THE ANTERIOR ABDOMINAL WALL. THE DURATION OF IMPLANTATION OF THE SUTURE ANCHOR IS NOT KNOWN. THE PATIENT REQUIRED REOPERATION AND CREATION OF A STOMA TO ADDRESS THE EVENT. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE PRODUCT INSERT INSTRUCTIONS FOR USE (IFU) STATES ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET IS INTENDED FOR ANCHORING THE ANTERIOR WALL OF THE STOMACH TO THE ABDOMINAL WALL PRIOR TO INTRODUCTION OF INTERVENTIONAL CATHETERS. PLACEMENT OF THE ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR WITHIN THE CAECUM IS NOT INDICATED IN THE INSTRUCTIONS FOR USE; THE DEVICE IS INTENDED TO BE USED AS AN ANCHOR WITHIN THE STOMACH.

  Patient problems: Fistula; No Code Available

  MAUDE report 6575022 ↗
• InjuryMay 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A CHAIT PERCUTANEOUS CECOSTOMY CATHETER WITH CECUM RETENTION ON AN UNSPECIFIED DATE. AN ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR WAS PLACED PERCUTANEOUSLY THROUGH THE ABDOMINAL WALL AND SET WITHIN THE PATIENT'S CAECUM. PLACEMENT OF THE CHAIT CECOSTOMY CATHETER WAS UNEVENTFUL. THE CUSTOMER REPORTED THAT THE ENTUIT SECURE GASTROINTESTINAL SUTURE "CHEESEWIRED" COMPLETELY THROUGH THE CAECUM AND CREATED A FISTULA TO THE ANTERIOR ABDOMINAL WALL. THE DURATION OF IMPLANTATION OF THE SUTURE ANCHOR IS NOT KNOWN. THE PATIENT REQUIRED REOPERATION AND CREATION OF A STOMA TO ADDRESS THE EVENT. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE PRODUCT INSERT INSTRUCTIONS FOR USE (IFU) STATES ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET IS INTENDED FOR ANCHORING THE ANTERIOR WALL OF THE STOMACH TO THE ABDOMINAL WALL PRIOR TO INTRODUCTION OF INTERVENTIONAL CATHETERS. PLACEMENT OF THE ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR WITHIN THE CAECUM IS NOT INDICATED IN THE INSTRUCTIONS FOR USE; THE DEVICE IS INTENDED TO BE USED AS AN ANCHOR WITHIN THE STOMACH.

  Patient problems: Fistula; No Code Available

  MAUDE report 6575011 ↗
• InjuryAug 25, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT HAD A GASTROPEXY WITH INSERTION OF A PERCUTANEOUS GASTROSTOMY TUBE ON (B)(6) 2016 AND DEVELOPED PRESSURE SORES AROUND THE ENTUIT SUTURE ANCHOR INSERTION SITE. REPORTEDLY THE PATIENT WAS BROUGHT BACK TO RADIOLOGY FOR SUTURE REMOVAL

  Patient problems: Suture Abrasion

  MAUDE report 5904498 ↗
• MalfunctionOct 31, 2014Migration or Expulsion of Device; Other (for use when an appropriate device code cannot be identified)

  DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE METAL T-PART OF THE ANCHORS (WHICH HAD BEEN IN PLACE FOR ABOUT THREE MONTHS) HAD PERFORATED THE STOMACH WALL AND MIGRATED INTO THE PERITONEAL SPACE, STILL CONNECTED TO THE OUTER FIXATION PART ON SKIN LEVEL. THE PATIENT DID NOT COMPLAIN ABOUT PAIN OR OTHER SYMPTOMS. THE PHYSICIAN IS AWARE THAT THE ANCHORS SHOULD BE REMOVED AFTER TWO WEEKS, BUT UNFORTUNATELY IN THIS CASE NOBODY TOOK CARE OF THIS. THE PHYSICIAN CLAIMED THIS FOR HIS OWN FAULT, NO FAILURE OF THE PRODUCT. IMPLANT (B)(6) 2014, EXPLANT (B)(6) 2014. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NO EXPERIENCE ANY ADVERSE EFFECTS TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 4320087 ↗