AVANOS 98433Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00350770984339), received between Dec 23, 2019 and Dec 12, 2025 — classified as 7 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (23 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED, ¿PATIENT ON THE TABLE WHO WAS HAVING A GASTROSTOMY TUBE PLACEMENT. IN THE PROCESS OF INSERTING THE GASTROSTOMY TUBE THROUGH THE DILATOR, A COUPLE OF LEVELS OF THE PEEL AWAY SHEATH DETACHED INSIDE THE STOMACH OF THE PATIENT. STATED THE PIECES ARE APPROXIMATELY 6¿ LONG. SHE SHARED THAT THE DOCTOR WAS IN THE PROCESS OF TRYING TO RETRIEVE THE PIECES OUT OF THE PATIENT AND IF NOT ABLE TO DO SO, THEY WERE GOING TO HAVE TO TAKE THE PATIENT TO SURGERY.¿

  Patient problems: Foreign Body In Patient

  MAUDE report 23789922 ↗
• MalfunctionSep 16, 2025Break; Break

  IT WAS REPORTED "THE PATIENT UNDERWENT ENDOSCOPIC GASTROSTOMY ON MONDAY, (B)(6). WHEN THE DRESSING WAS CHANGED ON DAY-1, TWO OF THE THREE ANCHOR PADS (REQUIRED FOR GASTROPEXY) FELL OFF." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 20-AUG-2025 STATED "NO MEDICAL INTERVENTION NEEDED." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23068936 ↗
• MalfunctionFeb 12, 2025Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2025-00015 FOR THE FIRST REPORT. IT WAS REPORTED, INSTALLATION OF GASTRONOMY TUBE ON (B)(6) 2025 UNDER ENDOSCOPY WITHOUT PROBLEM. ¿APPARENT LOSS OF HOLDING ANCHORS WITHIN 48 HOURS ON PATIENT HOSPITALIZED IN INTENSIVE CARE UNIT, RESULTING IN NON-ACCOLATION OF STOMACH AND SKIN. PERITONITIS OPERATED ON DURING THE NIGHT OF (B)(6) WITH FLUID IN THE PERITONEUM.¿ THE PRODUCT WAS IN USE FOR TWO DAYS. PATIENT INJURY INVOLVED ¿PERITONITIS DUE TO THE SKIN OF THE ESTOMAT AND THE BODY NOT STICKING TOGETHER.¿

  Patient problems: Peritonitis

  MAUDE report 21367951 ↗
• MalfunctionFeb 12, 2025Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2025-00017 FOR THE SECOND REPORT. IT WAS REPORTED, INSTALLATION OF GASTRONOMY TUBE ON (B)(6) 2025 UNDER ENDOSCOPY WITHOUT PROBLEM. ¿APPARENT LOSS OF HOLDING ANCHORS WITHIN 48 HOURS ON PATIENT HOSPITALIZED IN INTENSIVE CARE UNIT, RESULTING IN NON-ACCOLATION OF STOMACH AND SKIN. PERITONITIS OPERATED ON DURING THE NIGHT OF (B)(6) WITH FLUID IN THE PERITONEUM.¿ THE PRODUCT WAS IN USE FOR TWO DAYS. PATIENT INJURY INVOLVED ¿PERITONITIS DUE TO THE SKIN OF THE ESTOMAT AND THE BODY NOT STICKING TOGETHER.¿

  Patient problems: Peritonitis

  MAUDE report 21367948 ↗
• MalfunctionNov 21, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 20MAY2025 FROM MEDWATCH/ FDA USER FACILITY REPORT MW REPORT MW5164249: "ON (B)(6) 2024, THE PATIENT UNDERWENT G-TUBE PLACEMENT. AVANOS G-TUBE KIT WAS USED. ON (B)(6) 2024, A RETAINED FOREIGN BODY WAS IDENTIFIED ON THE CT(COMPUTED TOMOGRAPHY).AFTER THE FOREIGN BODY WAS RETRIEVED, IT WAS IDENTIFIED AS AN INNER PART OF THE TELESCOPIC DILATOR FROM THE G-TUBE KIT. CONSIDERING THE STRUCTURE OF THE DILATOR AND THE LACK OF RADIODENSITY, IT WAS NOT POSSIBLE TO IDENTIFY THE DETACHED PART OF THE DILATOR DURING THE PROCEDURE AND ON THE ABDOMINAL X-RAYS. IT WAS UNCLEAR HOW THE DETACHMENT OCCURRED. THE PART WAS SENT TO THE MANUFACTURER FOR INSPECTION¿

  Patient problems: Foreign Body In Patient

  MAUDE report 20746707 ↗
• MalfunctionMar 20, 2024Separation Problem; Separation Problem

  IT WAS REPORTED "SERIAL DILATION COMPLETED, PEEL AWAY SHEATH IN PLACE. PROXIMAL END OF DILATOR TWISTED TO RELEASE SHEATH, HOWEVER ONLY THE SMALLEST DILATOR WAS REMOVED. THE REMAINING SLEEVES OF DILATOR WERE STUCK TO SHEATH INSIDE PATIENT. INSTRUCTED TO REMOVE SHEATH [AND] REMAINING SLEEVES TOGETHER, AND PLACE DISTAL END OF GJ [GASTRO-JEJUNAL] TUBE IN STOMA TRACT AS T-FASTENERS WERE IN PLACE." THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18940819 ↗
• MalfunctionFeb 26, 2024Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2024-00015 FOR THE FIRST REPORT. IT WAS REPORTED, DURING ENDOSCOPIC PERCUTANEOUS GASTRONOMY PROCEDURE, TWO OUT OF THREE SUTURES BROKE WHEN THE DILATOR WAS INTRODUCED. A NEW KIT WAS OPEN TO REPLACE THE TWO T-FASTENERS. PATIENT WAS REPORTED TO BE OK. NO INJURY OR FURTHER MEDICAL INTERVENTIONS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 9FEB2024, ¿THERE WAS NO IMPACT ON THE PATIENT, WHO WAS IN GOOD CONDITION, JUST A DELAY IN THE OPERATION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784334 ↗
• MalfunctionFeb 26, 2024Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2024-00026 FOR THE SECOND REPORT. IT WAS REPORTED, DURING ENDOSCOPIC PERCUTANEOUS GASTRONOMY PROCEDURE, TWO OUT OF THREE SUTURES BROKE WHEN THE DILATOR WAS INTRODUCED. A NEW KIT WAS OPEN TO REPLACE THE TWO T-FASTENERS. PATIENT WAS REPORTED TO BE OK. NO INJURY OR FURTHER MEDICAL INTERVENTIONS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 9FEB2024, ¿THERE WAS NO IMPACT ON THE PATIENT, WHO WAS IN GOOD CONDITION, JUST A DELAY IN THE OPERATION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784331 ↗
• MalfunctionJul 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE WHITE TIP OF THE DILATOR BROKE OFF AND WAS ABLE TO BE RETRIEVED FROM THE PATIENT. NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17325327 ↗
• MalfunctionJan 30, 2023Break; Break

  IT WAS REPORTED THAT THREE ANCHORS WERE PLACED. WHEN THE PATIENT ARRIVED TO THE BED WARD, ONE SUTURE BROKE AND THE ANCHOR FELL OUT. NO MEDICAL INTERVENTIONS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 16 JAN 2023, THERE WAS NO INJURY TO THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED ON 18 JAN 2023, NO MEDICAL INTERVENTIONS WERE REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 16264991 ↗
• InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2022-00093 FOR THE FIRST EVENT. REFER TO 9611594-2022-00098 FOR THE THIRD EVENT. IT WAS REPORTED THE "T-PEXY/T-FASTENERS SEEM TOO TIGHT(SUTURES SEEM TOO SHORT- RETRACTED IN BUTTON PER INTERVENTIONAL RADIOLOGY PROVIDER), STAYING IN >4-6 WEEKS (NOT FALLING OUT ON THEIR OWN- OFTEN 1 BUTTON FALLS OFF BUT THE OTHER BUTTON REMAIN CONNECTED)." THE PATIENT EXPERIENCED ABDOMINAL CRAMPING, SPASM, A TWISTING FEELING AT NIGHT, AND TENDERNESS TO THE TOUCH. THE PHYSICIAN ASSISTANT (P.A.) THOUGHT THE PAIN AND CRAMPING "MAY BE RELATED TO REMAINING TPEXY THUS REMOVED TODAY IN CLINIC BY P.A. THE PATIENT REPORTED A MILD AMOUNT OF RELIEF FIVE MINUTES POST REMOVAL.

  Patient problems: Abdominal Cramps; Abdominal Pain; Cramp(s) /Muscle Spasm(s)

  MAUDE report 15009387 ↗
• InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2022-00093 FOR THE FIRST EVENT. REFER TO 9611594-2022-00097 FOR THE SECOND EVENT. IT WAS REPORTED THE "T-PEXY/T-FASTENERS SEEM TOO TIGHT(SUTURES SEEM TOO SHORT- RETRACTED IN BUTTON PER INTERVENTIONAL RADIOLOGY PROVIDER), STAYING IN >4-6 WEEKS (NOT FALLING OUT ON THEIR OWN- OFTEN 1 BUTTON FALLS OFF BUT THE OTHER BUTTON REMAIN CONNECTED)." THE PATIENT HAS HAD A NON-HEALING WOUND SINCE 21-DEC-2021 GASTROSTOMY TUBE PLACEMENT. WOUND CARE RECOMMENDED TO PLACE BANDAID(S) OVER PREVIOUS T-PEXY SITE WITH ANTIBACTERIAL OINTMENT.

  Patient problems: Post Operative Wound Infection

  MAUDE report 15009301 ↗
• InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2022-00097 FOR THE SECOND EVENT. REFER TO 9611594-2022-00098 FOR THE THIRD EVENT. IT WAS REPORTED THE "T-PEXY/T-FASTENERS SEEM TOO TIGHT(SUTURES SEEM TOO SHORT- RETRACTED IN BUTTON PER INTERVENTIONAL RADIOLOGY PROVIDER), STAYING IN >4-6 WEEKS (NOT FALLING OUT ON THEIR OWN- OFTEN 1 BUTTON FALLS OFF BUT THE OTHER BUTTON REMAIN CONNECTED)," INFECTION AT THE SITE.

  Patient problems: Unspecified Infection

  MAUDE report 15009182 ↗
• MalfunctionFeb 11, 2022Break; Break

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # (B)(4). THE FOLLOWING INFORMATION: DURING CT (COMPUTED TOMOGRAPHY) GUIDED IR (INTERVENTIONAL RADIOLOGY) PERCUTANEOUS GASTROSTOMY TUBE PLACEMENT, A SEGMENTED TELESCOPING DILATOR AND PEEL-AWAY SHEATH WAS THEN ADVANCED OVER THE WIRE AT THE CENTRAL ACCESS POINT AND DILATION WAS PERFORMED. THEN REMOVED; THIS REQUIRED GREATER THAN EXPECTED FORCE WHICH WAS THOUGHT TO BE DUE TO KINKING OF THE WIRE FOR DILATOR. WE THEN TRIED TO ADVANCE AN 18 FRENCH GASTROSTOMY TUBE INTO THE PEEL­ AWAY SHEATH WITHOUT SUCCESS. IT WAS SUBSEQUENTLY NOTED THAT A PORTION OF THE TELESCOPING DILATOR WAS STILL SITUATED WITHIN THE PEEL-AWAY SHEATH, THIS WAS GRASPED AND REMOVED WITH HEMOSTATS. THE TUBE WAS THEN SUCCESSFULLY PLACED THROUGH THE PEEL-AWAY SHEATH WHICH WAS THEN PEELED AND WITHDRAWN. AT THIS POINT, THE TECHNOLOGIST NOTED THAT AN ADDITIONAL PORTION OF THE TELESCOPING DILATOR WAS NOT ON THE PROCEDURE TRAY WE RESCANNED THE PATIENT WHICH DEMONSTRATED THE GASTROSTOMY TUBE WITH INFLATED BALLOON IN APPROPRIATE POSITION AND A SUBTLE RADIOLUCENT STRUCTURE WITHIN THE GASTRIC ANTRUM CORRESPONDING TO THE MISSING PORTION OF THE TELESCOPING DILATOR. WE CONTAC

  Patient problems: Foreign Body In Patient

  MAUDE report 13518955 ↗
• MalfunctionDec 7, 2021Break; Break

  IT WAS REPORTED THE T-FASTENERS BROKE DURING USE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12956891 ↗
• MalfunctionDec 1, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE SAF-T-PEXYS BROKE DURING A PROCEDURE. PER ADDITIONAL INFORMATION RECEIVED (B)(6) 2021, THERE WAS NO INJURY TO THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED (B)(6) 2021, TWO SUTURES BROKE DURING DILATION. THE PHYSICIAN WAS ABLE TO INSERT TWO NEW ANCHORS AFTER THE TUBE WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12913782 ↗
• MalfunctionDec 1, 2021Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2021-00172 FOR THE FIRST EVENT. REFER TO 9611594-2021-00173 FOR THE SECOND EVENT. IT WAS REPORTED DURING GASTROSTOMY TUBE PLACEMENT ALL OF THE GASTROPEXIES BROKE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12911618 ↗
• MalfunctionDec 1, 2021Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2021-00172 FOR THE FIRST EVENT. REFER TO 9611594-2021-00174 FOR THE THIRD EVENT. IT WAS REPORTED DURING GASTROSTOMY TUBE PLACEMENT ALL OF THE GASTROPEXIES BROKE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12911568 ↗
• MalfunctionDec 1, 2021Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2021-00173 FOR THE SECOND EVENT. REFER TO 9611594-2021-00174 FOR THE THIRD EVENT. IT WAS REPORTED DURING GASTROSTOMY TUBE PLACEMENT ALL OF THE FOUR GASTROPEXIES "BROKE OFF WHILE ADVANCING THE DILATOR." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12911515 ↗
• InjuryFeb 5, 2021Separation Failure; Separation Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2021-00007 FOR THE FIRST EVENT. REFER TO 9611594-2021-00008 FOR THE SECOND EVENT. IT WAS REPORTED THE SUTURES WERE NOT DISSOLVING CAUSING THE PATIENT'S SKIN TO BECOME "ERODED." ADDITIONAL INFORMATION RECEIVED 18-JAN-2021 STATED THE PATIENT WENT TO THE OUTPATIENT CLINIC FOR REMOVAL OF THE DEVICE.

  Patient problems: Erosion

  MAUDE report 11288905 ↗
• InjuryFeb 5, 2021Separation Failure; Separation Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2021-00007 FOR THE FIRST EVENT. REFER TO 9611594-2021-00009 FOR THE THIRD EVENT. IT WAS REPORTED THE SUTURES WERE NOT DISSOLVING CAUSING THE PATIENT'S SKIN TO BECOME "ERODED." ADDITIONAL INFORMATION RECEIVED 18-JAN-2021 STATED THE PATIENT WENT TO THE EMERGENCY ROOM (ER) FOR ASSESSMENT DUE TO PAIN AT GASTROSTOMY TUBE SITE. THE PATIENT HAS AN APPOINTMENT WITH THE HEMATOLOGY/ONCOLOGY TO ASSESS PAIN AT GASTROSTOMY SITE. THE PATIENT WENT TO THE OUTPATIENT CLINIC FOR REMOVAL OF THE DEVICE.

  Patient problems: Erosion

  MAUDE report 11288865 ↗
• InjuryFeb 5, 2021Separation Failure; Separation Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2021-00008 FOR THE SECOND EVENT. REFER TO 9611594-2021-00009 FOR THE THIRD EVENT. IT WAS REPORTED THE SUTURES WERE NOT DISSOLVING CAUSING THE PATIENT'S SKIN TO BECOME "ERODED." ADDITIONAL INFORMATION RECEIVED 18-JAN-2021 THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE SUTURES WERE REMOVED WHILE THE PATIENT WAS INPATIENT.

  Patient problems: Erosion

  MAUDE report 11288833 ↗
• MalfunctionJan 12, 2021Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2021-00001 FOR THE FIRST EVENT. REFER TO 9611594-2021-00002 FOR THE SECOND EVENT. IT WAS REPORTED THE SUTURES ON THE T-FASTENERS BROKE DURING INITIAL USE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11154796 ↗
• MalfunctionJan 11, 2021Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2021-00002 FOR THE SECOND EVENT. REFER TO 9611594-2021-00003 FOR THE THIRD EVENT. IT WAS REPORTED THE SUTURES ON THE T-FASTENERS BROKE DURING INITIAL USE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11152688 ↗
• MalfunctionJan 11, 2021Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2021-00001 FOR THE FIRST EVENT. REFER TO 9611594-2021-00003 FOR THE THIRD EVENT. IT WAS REPORTED THE SUTURES ON THE T-FASTENERS BROKE DURING INITIAL USE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11152686 ↗