EntuitRecalls & reported problems across all models
Cook Incorporated · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Entuit model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 30
- Deaths reported
- 1
- Injuries reported
- 23
- Recalls
- 1
We found 5 models of Entuit by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Oct 31, 2014 and Feb 15, 2021 — classified as 1 death, 23 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Difficult To Position” (2 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Entuit recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 Entuit problems
Device problems
- Adverse Event Without Identified Device or Use Problem13
- Difficult To Position2
- Material Frayed2
- Material Separation2
- Migration or Expulsion of Device2
- Air Leak1
- Appropriate Device Problem Term/Code Not Available1
- Break1
Patient problems
- No Code Available12
- No Known Impact Or Consequence To Patient6
- Inflammation5
- Unspecified Infection5
- Erosion4
- Necrosis4
- Purulent Discharge4
- Fistula2
Entuit models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Entuit G35562CATHETER, BILIARY, DIAGNOSTIC1 recall4 reports
- Entuit G35563CATHETER, BILIARY, DIAGNOSTIC9 reports
- Entuit G34443TUBE, GASTRO-ENTEROSTOMY1 death8 reports
- Entuit G35570CATHETER, BILIARY, DIAGNOSTIC6 reports
- Entuit G35569CATHETER, BILIARY, DIAGNOSTIC3 reports
Recent Entuit adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 15, 2021Migration or Expulsion of Device; Migration or Expulsion of Device
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient; No Code Available; Purulent Discharge
MAUDE report 11330206 ↗MalfunctionApr 6, 2020Material Frayed; Material Frayed
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9929577 ↗MalfunctionApr 6, 2020Material Frayed; Material Frayed
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9929525 ↗MalfunctionJul 26, 2019Dull, Blunt; Dull, Blunt
IT WAS REPORTED AN ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET WAS USED DURING A GASTROSTOMY IN AN UNKNOWN PATIENT. THE OPERATOR REPORTED THE NEEDLE WAS "BLUNT." IT WAS FURTHER REPORTED THAT THE STOMACH "EVADES, "BECAUSE THE NEEDLE IS TOO DULL." ANCHORS WERE SUCCESSFULLY PLACED DURING THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8833659 ↗InjuryApr 1, 2019Migration; Migration
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Inflammation; No Code Available
MAUDE report 8469988 ↗MalfunctionMay 15, 2018Material Rupture; Material Rupture
IT WAS REPORTED AN ENTUIT START INITIAL PLACEMENT GASTROSTOMY TUBE BURST AND CAME OUT OF A PATIENT. TO DATE, ADDITIONAL INFORMATION REGARDING THE PATIENT AND EVENT IS UNKNOWN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7516082 ↗InjuryMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED AN ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET WIRE WAS TOO LARGE FOR A CHILD. BEFORE PLACING THE GASTROINTESTINAL TUBE, THE WIRE WAS UNABLE TO BE REMOVED; THEREFORE, IT WAS REMOVED THROUGH ENDOSCOPY. THE REPORTED DEVICE IS INTENDED FOR ANCHORING THE ANTERIOR WALL OF THE STOMACH TO THE ABDOMINAL WALL PRIOR TO INTRODUCTION OF INTERVENTIONAL CATHETERS. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. TO DATE, ADDITIONAL PATIENT AND EVENT INFORMATION HAVE NOT BEEN MADE AVAILABLE. THE REPORTED DEVICE DID NOT MALFUNCTION; HOWEVER, THE SURGICAL PLAN WAS ADJUSTED TO REMOVE THE WIRE.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 7497968 ↗InjuryJan 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE INTERNATIONAL CUSTOMER REPORTED THAT 10 DAYS FOLLOWING PLACEMENT OF THE ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET, THE PATIENT PRESENTED WITH PUS-CONTAINING AND NECROTIC WOUNDS, WHICH WERE LOCATED UNDER THE ANCHORS. THE PRODUCT ISSUE NECESSITATED THE DISINFECTION AND WOUND CARE MEASURES. THE CUSTOMER CONFIRMED THAT WHEN DEPLOYING THE ADJUSTABLE ANCHORS, SLIGHTLY LOOSENING THEM AFTER PLACEMENT AVOIDS THE PROBLEM OF NECROTIZING IRRITATION. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.
Patient problems: Pressure Sore/Ulcer; Purulent Discharge
MAUDE report 7219574 ↗MalfunctionNov 30, 2017Unraveled Material; Unraveled Material
THE INTERNATIONAL CUSTOMER REPORTED THAT THE BRAIDING OF THE ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR CAME APART AT THE PROXIMAL END OF THE DEVICE WHEN THE OPERATOR WAS TRYING TO ADVANCE THE WHITE TOGGLE DOWN THE SUTURE TO SECURE THE SUTURE ANCHOR IN PLACE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING TWO OTHER GASTROPEXY SUTURES THAT WERE CONTAINED IN THE SAME KIT. THE CUSTOMER CONFIRMED THAT NO ADDITIONAL PROCEDURES WERE REQUIRED AND NO PATIENT ADVERSE EVENTS OCCURRED AS A RESULT OF THE PRODUCT ISSUE. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION. AFTER FURTHER REVIEW OF THE RECORD, IT WAS DETERMINED THAT IT SHOULD BE NOTED THAT THE CUSTOMER REPORTED THAT, TO COMPLETE THE PROCEDURE SUCCESSFULLY, THE WHITE TOGGLE OF THE DEVICE WAS CUT AT THE SKIN SO THAT THE SUTURE COULD BE PASSED AS INTENDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7073109 ↗InjuryNov 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE INTERNATIONAL CUSTOMER REPORTED THAT, APPROXIMATELY 1 WEEK FOLLOWING THE UNEVENTFUL INSERTION OF A PERCUTANEOUS RADIO-GUIDED GASTROSTOMY, AN OPENING OCCURRED AT THE PERIPHERY OF THE GASTROSTOMY ORIFICE. LEAKAGE OF THE GASTRIC FLUID AND INFLAMMATION OF THE PATIENT'S CUTANEOUS SKIN WERE REPORTED. THE GASTROSTOMY FEEDING TUBE WAS EXCHANGED FOR A LARGER SIZED FEEDING TUBE IN AN ATTEMPT TO RESTORE THE SEAL AT THE GASTROSTOMY SITE. ANTIBIOTICS, SKIN CARE, AND PROTON PUMP INHIBITORS WERE ADMINISTERED. CLINICAL MONITORING WAS PERFORMED AS A PRECAUTION, AND THE USAGE OF THIS DEVICE WAS REPORTEDLY HALTED BY THE CUSTOMER TEMPORARILY. IT IS NOT KNOWN WHETHER OR NOT THE DEVICE WILL BE RETURNED; AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.
Patient problems: Erosion; Inflammation; No Code Available
MAUDE report 7007596 ↗InjuryNov 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE INTERNATIONAL CUSTOMER REPORTED THAT, APPROXIMATELY 1 WEEK FOLLOWING THE UNEVENTFUL INSERTION OF A PERCUTANEOUS RADIO-GUIDED GASTROSTOMY, AN OPENING OCCURRED AT THE PERIPHERY OF THE GASTROSTOMY ORIFICE. LEAKAGE OF THE GASTRIC FLUID AND INFLAMMATION OF THE PATIENT'S CUTANEOUS SKIN WERE REPORTED. THE GASTROSTOMY FEEDING TUBE WAS EXCHANGED FOR A LARGER SIZED FEEDING TUBE IN AN ATTEMPT TO RESTORE THE SEAL AT THE GASTROSTOMY SITE. ANTIBIOTICS, SKIN CARE, AND PROTON PUMP INHIBITORS WERE ADMINISTERED. CLINICAL MONITORING WAS PERFORMED AS A PRECAUTION, AND THE USAGE OF THIS DEVICE WAS REPORTEDLY HALTED BY THE CUSTOMER TEMPORARILY. IT IS NOT KNOWN WHETHER OR NOT THE DEVICE WILL BE RETURNED; AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.
Patient problems: Erosion; Inflammation; No Code Available
MAUDE report 7007588 ↗InjuryNov 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE INTERNATIONAL CUSTOMER REPORTED THAT, APPROXIMATELY 1 WEEK FOLLOWING THE UNEVENTFUL INSERTION OF A PERCUTANEOUS RADIO-GUIDED GASTROSTOMY, AN OPENING OCCURRED AT THE PERIPHERY OF THE GASTROSTOMY ORIFICE. LEAKAGE OF THE GASTRIC FLUID AND INFLAMMATION OF THE PATIENT'S CUTANEOUS SKIN WERE REPORTED. THE GASTROSTOMY FEEDING TUBE WAS EXCHANGED FOR A LARGER SIZED FEEDING TUBE IN AN ATTEMPT TO RESTORE THE SEAL AT THE GASTROSTOMY SITE. ANTIBIOTICS, SKIN CARE, AND PROTON PUMP INHIBITORS WERE ADMINISTERED. CLINICAL MONITORING WAS PERFORMED AS A PRECAUTION, AND THE USAGE OF THIS DEVICE WAS REPORTEDLY HALTED BY THE CUSTOMER TEMPORARILY. IT IS NOT KNOWN WHETHER OR NOT THE DEVICE WILL BE RETURNED; AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.
Patient problems: Erosion; Inflammation; No Code Available
MAUDE report 7007586 ↗InjuryNov 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE INTERNATIONAL CUSTOMER REPORTED THAT, APPROXIMATELY 1 WEEK FOLLOWING THE UNEVENTFUL INSERTION OF A PERCUTANEOUS RADIO-GUIDED GASTROSTOMY, AN OPENING OCCURRED AT THE PERIPHERY OF THE GASTROSTOMY ORIFICE. LEAKAGE OF THE GASTRIC FLUID AND INFLAMMATION OF THE PATIENT'S CUTANEOUS SKIN WERE REPORTED. THE GASTROSTOMY FEEDING TUBE WAS EXCHANGED FOR A LARGER SIZED FEEDING TUBE IN AN ATTEMPT TO RESTORE THE SEAL AT THE GASTROSTOMY SITE. ANTIBIOTICS, SKIN CARE, AND PROTON PUMP INHIBITORS WERE ADMINISTERED. CLINICAL MONITORING WAS PERFORMED AS A PRECAUTION, AND THE USAGE OF THIS DEVICE WAS REPORTEDLY HALTED BY THE CUSTOMER TEMPORARILY. IT IS NOT KNOWN WHETHER OR NOT THE DEVICE WILL BE RETURNED; AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.
Patient problems: Erosion; Inflammation; No Code Available
MAUDE report 7007339 ↗InjurySep 7, 2017Positioning Problem; Positioning Problem
THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN EMPLOYING THE ENTUIT START INITIAL PLACEMENT GASTROSTOMY SET DURING THE PROCEDURE ON (B)(6) 2017, THE GASTROSTOMY BECAME DISPLACED DURING THE FINAL PART OF THE PROCEDURE AND IT HAD TO BE REMOVED. THE GASTROSTOMY WAS LATER RE-ATTEMPTED AND COMPLETED SUCCESSFULLY ON (B)(6) 2017. THE DELAY NECESSITATED THE USE OF A NASOGASTRIC TUBE FOR PATIENT NUTRITION UNTIL THE COMPLETION OF THE SECOND PROCEDURE. THE CIRCUMSTANCES SURROUNDING THE HANDLING AND USAGE OF THE DEVICE ARE NOT KNOWN. THE CUSTOMER HAS NOT INDICATED WHETHER OR NOT THE PRODUCT WILL BE RETURNED; AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION.
Patient problems: No Code Available
MAUDE report 6847692 ↗InjuryAug 31, 2017Air Leak; Air Leak
IT WAS REPORTED BY THE INTERNATIONAL CUSTOMER THAT THE OPERATOR MADE 2 OR 3 ATTEMPTS TO PLACE THE FEEDING TUBES USING THE PRODUCT; HOWEVER, AIR WAS LEAKING FROM THE STOMACH. THE PROCEDURE WAS NOT SUCCESSFUL AS A RESULT. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED ON THE SAME DAY AS A PRECAUTION. THE PATIENT ELECTED NOT TO HAVE SURGICAL INTERVENTION DUE TO THE RISKS INVOLVED, AND EXPERIENCED SEVERE ABDOMINAL PAIN DUE TO THE FAILURE OF THE DEVICE.
Patient problems: Pain
MAUDE report 6834150 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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