AVANOS 44599Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00350770445991), received between Mar 4, 2022 and Apr 3, 2025 — classified as 12 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Break” (14 reports).

14 other recalls cover devices cleared under the same FDA submission (K924065); they may or may not involve this specific model.

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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2025Device Slipped; Device Slipped

  IT WAS REPORTED THE "PATIENT UNDERWENT SCHEDULED OUTPATIENT EGD (ESOPHAGOGASTRODUODENOSCOPY) WITH G-TUBE (GASTROSTOMY TUBE) PLACEMENT. DURING THE G-TUBE INSERTION, THE CLEAR PLASTIC CATHETER SLOWLY BEGAN DISAPPEARING INTO THE PATIENT'S SUBCUTANEOUS ADIPOSE TISSUE. [THE CLINICAL TEAM] LOST ENDOSCOPIC VISUALIZATION. FORTUNATELY, IT WAS QUICKLY RETRIEVED WITH A KELLY CLAMP BY THE GI (GASTROINTESTINAL) FELLOW. THE G-TUBE WAS ABLE TO BE PLACED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21763079 ↗
• InjurySep 20, 2024Malposition of Device; Malposition of Device

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 3006646024-2024-00026 FOR THE FIRST EVENT. REFER TO 3006646024-2024-00027 FOR THE SECOND EVENT. REFER TO 3006646024-2024-00028 FOR THE THIRD EVENT. IT WAS REPORTED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PLACEMENT OF PEG TUBE, THERE WAS AN ESOPHAGEAL SUPERFICIAL TEAR VISUALIZED AFTER PULLING THE PEG TUBE OVER THE GUIDEWIRE. THE PHYSICIAN HAD TO PLACE A CLIP TO CLOSE THE MUCOSAL TEAR.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 20274688 ↗
• InjurySep 19, 2024Malposition of Device; Malposition of Device

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 3006646024-2024-00026 FOR THE FIRST EVENT. REFER TO 3006646024-2024-00027 FOR THE SECOND EVENT. REFER TO 3006646024-2024-00028 FOR THE THIRD EVENT. IT WAS REPORTED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PLACEMENT OF PEG TUBE, THERE WAS AN ESOPHAGEAL SUPERFICIAL TEAR VISUALIZED AFTER PULLING THE PEG TUBE OVER THE GUIDEWIRE. THE PHYSICIAN HAD TO PLACE A CLIP TO CLOSE THE MUCOSAL TEAR.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 20260608 ↗
• InjurySep 19, 2024Malposition of Device; Malposition of Device

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 3006646024-2024-00026 FOR THE FIRST EVENT. REFER TO 3006646024-2024-00028 FOR THE THIRD EVENT. REFER TO 3006646024-2024-00029 FOR THE FOURTH EVENT. IT WAS REPORTED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PLACEMENT OF PEG TUBE, THERE WAS AN ESOPHAGEAL SUPERFICIAL TEAR VISUALIZED AFTER PULLING THE PEG TUBE OVER THE GUIDEWIRE. NO ADDITIONAL INFORMATION WAS PROVIDED FOR THIS EVENT.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 20260451 ↗
• InjurySep 19, 2024Malposition of Device; Malposition of Device

  ADDITIONAL INFORMATION RECEIVED 26-FEB-2025 VIA MEDWATCH/ FDA USER FACILITY REPORT MW REPORT MW20705566 STATING: "TO RN COORDINATOR BY DR. AS DISCUSSED, I HAVE PLACED TWO PEG TUBES ON MY CALL WEEK. BOTH PROCEDURES HAD AN ESOPHAGEAL SUPERFICIAL TEAR VISUALIZED AFTER PULLING THE PEG TUBE OVER THE GUIDEWIRE AVANOS REF#(B)(4), LOT#30297186. IN BOTH INSTANCES, I HAD TO PLACE A CLIP TO CLOSE THE MUCOSAL TEAR. PLEASE SEE IF THESE PEG TUBE LOT CAN BE INVESTIGATED OR ALTERNATIVELY SWITCHED TO A DIFFERENT BRAND. I HAVE NEVER HAD AN ISSUE IN THE PAST. MY FEELING IS THAT THE BUMPER OR PLASTIC CATHETER IS TOO SHARP OR STIFF."

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 20260100 ↗
• InjurySep 19, 2024Malposition of Device; Malposition of Device

  ADDITIONAL INFORMATION RECEIVED 26-FEB-2025 VIA MEDWATCH/ FDA USER FACILITY REPORT MW REPORT MW20694048 STATING: "DURING AN EGD WITH PLACEMENT OF PEG TUBE, THERE WAS AN ESOPHAGEAL SUPERFICIAL TEAR VISUALIZED AFTER PULLING THE PEG TUBE OVER THE GUIDEWIRE. THEY HAD TO PLACE A CLIP TO CLOSE THE MUCOSAL TEAR. THE MD REPORTED TO WRITER VIA EMAIL THAT THIS HAS ALSO HAPPENED ONCE WITH THE SAME PRODUCT. WRITER INVESTIGATED AND FOUND THAT THE PEG TUBE KITS USED IN EACH INSTANCE WERE DIFFERENT LOT NUMBERS. THIS PRODUCT HAS BEEN USED IN OUR FACILITY FOR OVER 2 YEARS WITHOUT ANY SIMILAR INCIDENTS. THE PRODUCT USED IN THIS INSTANCE WAS AN AVANOS 20 FR MIC* SAFETY PEG KIT- PULL METHOD, CATALOG # 8180-20, LOT # 30264943, EXP DATE 2/28/2025. THE MD STATED IN HIS EMAIL TO WRITER: "PLEASE SEE IF THESE PEG TUBE LOT CAN BE INVESTIGATED OR ALTERNATIVELY SWITCHED TO A DIFFERENT BRAND. I HAVE NEVER HAD AN ISSUE WITH THESE IN THE PAST. MY FEELING IS THAT THE BUMPER OR PLASTIC CATHETER IS TOO SHARP OR STIFF."

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 20260054 ↗
• MalfunctionMay 15, 2024Break; Difficult to Open or Close; Material Deformation; Material Twisted/Bent; Break; Difficult to Open or Close; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE TROCAR OR CANNULA FROM THE INTRODUCER NEEDLE FEEL INTO THE PATIENT DURING THE PROCEDURE, WHEN THEY TRIED TO RETRIEVE THE ITEM FROM INSIDE THE PATIENT WITH OUR RETRIEVAL SNARE, THE SNARE BROKE AND THEY COULDN¿T PUSH THE HANDLE OF THE SNARE IN TO CLOSE THE LOOP OF THE SNARE. THEY ENDED UP HAVING TO USE AND PULL THE PREVIOUS/COMPETING BOSTON SCI KIT IN THE MIDDLE OF THE PROCEDURE, TO PLACE A NEW TROCAR/CANNULA AND RETRIEVE THE LOST AVANOS CANNULA. FORTUNATELY, THEY WERE ABLE TO RETRIEVE THE LOST AVANOS CANNULA, AND NO INJURY OCCURRED TO THE PATIENT. THE PROCEDURE THAT TOOK MORE THAN DOUBLE THE AMOUNT OF TIME TO COMPLETE DUE TO THE COMPLICATION. PER ADDITIONAL INFORMATION RECEIVED ON 19-APR-2024, ¿AFTER THE DOCTOR INSERTED THE INTRODUCER SAFETY NEEDLE THROUGH THE INCISION, THE DOCTOR WAS UNABLE TO REMOVE THE NEEDLE WITHOUT APPLYING EXTREME FORCE. WHEN HE WAS FINALLY ABLE TO DISLODGE THE NEEDLE, IMAGING FROM THE ENDOSCOPY SCOPE SHOWED THAT THE INTRODUCER SHEATH WAS BENT. AT THIS TIME, THE DOCTOR TRIED ADVANCING THE WIRE BUT WAS UNABLE DUE TO THE SHEATH MALFORMATION. THE DOCTOR THEN TRIED TO UTILIZE THE SNARE TO MANIPULATE THE SHEATH. THE SNARE WAS ABLE TO OPEN B

  Patient problems: Foreign Body In Patient

  MAUDE report 19320841 ↗
• MalfunctionApr 26, 2024Break; Break

  IT WAS REPORTED THAT " ON WEDNESDAY, ON (B)(6) 2024 AT 9:15AM, DURING A PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY) TUBE PLACEMENT A PIECE OF THE PLASTIC INTRODUCER SHEATH BROKE OFF INTO THE PATIENT¿S ABDOMINAL WALL. [THE] PHYSICIAN WAS ATTEMPTING TO THREAD THE GUIDE WIRE THROUGH THE INTRODUCER AND WAS UNSUCCESSFUL. WHEN [THE PHYSICIAN] PULLED THE NEEDLE FROM THE INTRODUCER THE PLASTIC SHEATH DISAPPEARED INTO THE PATIENT¿S ABDOMEN. [THE PHYSICIAN] ATTEMPTED TO RETRIEVE THE PLASTIC SHEATH BUT WAS UNABLE TO UNSUCCESSFUL. PATIENT WAS TAKEN TO SURGERY FOR FOREIGN BODY REMOVAL AND PEG TUBE PLACEMENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 19191704 ↗
• MalfunctionApr 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A PART OF THE KIT WAS "LEFT IN THE PATIENT." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19138840 ↗
• MalfunctionApr 18, 2024Break; Material Separation; Break; Material Separation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3006646024-2024-00020 FOR THE SECOND REPORT. IT WAS REPORTED, DURING REMOVAL OF GASTRONOMY TUBES, THE RETENTION END OF THE TUBE BROKE OFF AND WAS RETAINED IN THE PATIENT¿S STOMACH. PER ADDITIONAL INFORMATION RECEIVED ON 29-MAR-2024, THERE WAS NO INJURY TO THE PATIENT. PATIENT UNDERWENT UNSUCCESSFUL ENDOSCOPY RETRIEVAL- FOLLOWED BY COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN/PELVIS TO LOCATE. THE PATIENT IS FOLLOWING UP MEDICALLY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19130298 ↗
• MalfunctionApr 18, 2024Break; Material Separation; Break; Material Separation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3006646024-2024-00019 FOR THE FIRST REPORT. IT WAS REPORTED, DURING REMOVAL OF GASTRONOMY TUBES, THE RETENTION END OF THE TUBE BROKE OFF AND WAS RETAINED IN THE PATIENT¿S STOMACH. PER ADDITIONAL INFORMATION RECEIVED ON 29-MAR-2024, THERE WAS NO INJURY TO THE PATIENT. ABDOMINAL X-RAY OBTAINED. THE PATIENT IS FOLLOWING UP MEDICALLY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19130253 ↗
• MalfunctionApr 10, 2024Difficult to Fold, Unfold or Collapse; Difficult to Remove; Difficult to Fold, Unfold or Collapse; Difficult to Remove

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3006646024-2024-00013 FOR THE FIRST REPORT. REFER TO 3006646024-2024-00015 FOR THE THIRD REPORT. IT WAS REPORTED, ¿SEVERAL OF THE DOCTORS HAVE HAD ISSUES WITH THE BUMPER (PIECE THAT HOLDS THE TUBE INSIDE THE STOMACH). WHEN THEY NEED TO DO A PEG EXCHANGE, OR JUST REMOVE THE PEG, NORMALLY THEY SHOULD BE ABLE TO PULL IT OUT OF THEIR STOMACH, FROM THE OUTSIDE OF THEIR BODY WITHOUT A SCOPE. HOWEVER, THERE HAVE BEEN ISSUES LATELY PULLING IT OUT. SO INSTEAD, WE CAN DO A SCOPE, AND CUT THE TUBE FROM THE OUTSIDE, GRAB AROUND THE BUMPER FROM INSIDE THE STOMACH WITH A SCOPE, AND PULL WHAT IS LEFT BACK THROUGH THE MOUTH." PER ADDITIONAL INFORMATION RECEIVED ON 22-MAR-2024, ¿THERE HAVE BEEN NO PATIENT DEATHS, BUT WE HAVE HAD PATIENTS EXPERIENCE SOME IRRITATION IN THEIR ESOPHAGUS AND MILD TEARING FROM TRYING TO PULL THE BUMPER OUT.¿

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 19078028 ↗
• MalfunctionApr 10, 2024Difficult to Fold, Unfold or Collapse; Difficult to Remove; Difficult to Fold, Unfold or Collapse; Difficult to Remove

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3006646024-2024-00014 FOR THE SECOND REPORT. REFER TO 3006646024-2024-00015 FOR THE THIRD REPORT. IT WAS REPORTED, ¿SEVERAL OF THE DOCTORS HAVE HAD ISSUES WITH THE BUMPER (PIECE THAT HOLDS THE TUBE INSIDE THE STOMACH). WHEN THEY NEED TO DO A PEG EXCHANGE, OR JUST REMOVE THE PEG, NORMALLY THEY SHOULD BE ABLE TO PULL IT OUT OF THEIR STOMACH, FROM THE OUTSIDE OF THEIR BODY WITHOUT A SCOPE. HOWEVER, THERE HAVE BEEN ISSUES LATELY PULLING IT OUT. SO INSTEAD, WE CAN DO A SCOPE, AND CUT THE TUBE FROM THE OUTSIDE, GRAB AROUND THE BUMPER FROM INSIDE THE STOMACH WITH A SCOPE, AND PULL WHAT IS LEFT BACK THROUGH THE MOUTH. WE HAD A PATIENT YESTERDAY THAT WE TRIED TO DO THIS WITH, BUT EVEN THEN, THE BUMPER WAS GETTING CAUGHT AT THE GE JUNCTION AND WOULD NOT PASS THROUGH THE ESOPHAGUS. DR. WAS DOING THIS PROCEDURE AND TRYING VARIOUS TOOLS TO GET THE PIECE OUT, AND THEN SHE ALSO CALLED ANOTHER DOCTOR TO COME OVER AS WELL. THE PROCEDURE, WHICH SHOULD HAVE TAKEN 5-10 MINUTES, ENDED UP TAKING AN HOUR, A

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 19078026 ↗
• MalfunctionApr 10, 2024Difficult to Fold, Unfold or Collapse; Difficult to Remove; Difficult to Fold, Unfold or Collapse; Difficult to Remove

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3006646024-2024-00013 FOR THE FIRST REPORT. REFER TO 3006646024-2024-00014 FOR THE SECOND REPORT. IT WAS REPORTED, ¿SEVERAL OF THE DOCTORS HAVE HAD ISSUES WITH THE BUMPER (PIECE THAT HOLDS THE TUBE INSIDE THE STOMACH). WHEN THEY NEED TO DO A PEG EXCHANGE, OR JUST REMOVE THE PEG, NORMALLY THEY SHOULD BE ABLE TO PULL IT OUT OF THEIR STOMACH, FROM THE OUTSIDE OF THEIR BODY WITHOUT A SCOPE. HOWEVER, THERE HAVE BEEN ISSUES LATELY PULLING IT OUT. SO INSTEAD, WE CAN DO A SCOPE, AND CUT THE TUBE FROM THE OUTSIDE, GRAB AROUND THE BUMPER FROM INSIDE THE STOMACH WITH A SCOPE, AND PULL WHAT IS LEFT BACK THROUGH THE MOUTH." PER ADDITIONAL INFORMATION RECEIVED ON 22-MAR-2024, ¿THERE HAVE BEEN NO PATIENT DEATHS, BUT WE HAVE HAD PATIENTS EXPERIENCE SOME IRRITATION IN THEIR ESOPHAGUS AND MILD TEARING FROM TRYING TO PULL THE BUMPER OUT.¿

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 19078013 ↗
• MalfunctionJan 15, 2024Break; Break

  IT WAS REPORTED, THE PHYSICIAN WAS IN THE INTENSIVE CARE UNIT (ICU) PERFORMING A PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY) PROCEDURE AND HAD ISSUE WITH THE TROCAR (SAFETY NEEDLE)...LODGED IN THE ABDOMINAL WALL AND WHEN ATTEMPTING TO RETRIEVE IT, THE TIP OF THE TROCAR BROKE OFF. PATIENT REQUIRED SURGERY TO RETRIEVE THE BROKEN TIP." ADDITIONAL INFORMATION RECEIVED 04-JAN-2024 STATING THE CLINICIANS "PERFORMED AN EXPLORATORY LAPAROTOMY, PARTIAL COLECTOMY, REPAIR OF SMALL BOWEL, OMENTECTOMY, COLOSTOMY CREATION, VENTRAL HERNIA REPAIR, WOUND EXPLORATION AND FOREIGN BODY REMOVAL, GASTROSTOMY TUBE PLACEMENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 18510896 ↗
• MalfunctionJan 6, 2024Material Separation; Material Separation

  IT WAS REPORTED THERE WAS AN EVENT WHERE THE WHITE CATHETER SLIPPED THROUGH THE INCISION AND HAD TO BE RETRIEVED WITH A GRASPER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18461121 ↗
• MalfunctionDec 21, 2023Difficult to Fold, Unfold or Collapse; Difficult to Remove; Inadequacy of Device Shape and/or Size; Difficult to Fold, Unfold or Collapse; Difficult to Remove; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED, THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WAS UNABLE TO BE REMOVED BY TRACTION REMOVAL DESPITE USING PROPER TECHNIQUE. THE PEG HAD TO BE REMOVED VIA ENDOSCOPY THROUGH THE PATIENT MOUTH. THERE WAS NO INJURY REPORTED. ENDOSCOPY REPORT NOTED: ¿STOMACH: THE TRACTION-REMOVABLE PEG WAS IDENTIFIED IN THE STOMACH BODY. THE BUMPER WAS FREELY MOBILE AND NOT [BURIED]. WE INITIALLY ATTEMPTED TRACTION REMOVAL UNDER ENDOSCOPIC VISUALIZATION. THE BUMPER IS SOMEWHAT BROADER THAN OTHER TRACTION REMOVABLE BUMPERS AND MORE ELASTIC. AS SUCH, ONCE THE BUMPER COLLAPSED AS IT WAS PASSING INTO THE PEG TRACT, IT WOULD SPRING BACK INTO THE GASTRIC BODY, PREVENTING REMOVAL. WE THEN DECIDED TO REMOVE THE BUMPER THROUGH THE MOUTH. WE SECURED THE BUMPER WITH A ROTH NET, THEN CUT THE PEG TUBING ABOUT 5 CM FROM THE SKIN. WE WERE THEN ABLE TO REMOVE THE PEG THROUGH THE MOUTH. DUODENUM: THE DUODENAL MUCOSA SHOWED NO ABNORMALITIES IN THE ENTIRE DUODENUM. THE GASTROSCOPE WAS THE SLOWLY WITHDRAWN AND REMOVED.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18372139 ↗
• MalfunctionJul 13, 2023Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3006646024-2023-00031 FOR THE SECOND EVENT. IT WAS REPORTED "THE PHYSICIAN HAD MADE THE INCISION AND PUT NEEDLE IN, AND WHEN HE WENT TO PULL THE NEEDLE OUT AND ENGAGED THE SAFETY, THE CANNULA WOUND UP IN THE PERITONEUM. PHYSICIAN WAS ABLE TO RETRIEVE AND THERE WAS NO HARM." THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17321568 ↗
• MalfunctionJul 13, 2023Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3006646024-2023-00030 FOR THE FIRST EVENT. IT WAS REPORTED WHEN THE PHYSICIAN UTILIZED THE "SAFETY LOCKED AND BEGAN PULLING NEEDLE OUT, THE CANNULA BEGAN SLIPPING DOWN INTO THE INCISION." THE GENERAL SURGEON HAD TO COME IN AND RETRIEVE THE CANNULA FROM THE PERITONEUM. THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17321213 ↗
• MalfunctionJul 7, 2023Break; Break

  IT WAS REPORTED VIA FDA MEDWATCH, MW5118688 THE FOLLOWING INFORMATION: EGD (ESOPHAGOGASTRODUODENOSCOPY)/PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY) PROCEDURE. SURGEON ATTEMPTED TO PLACE A PEG TUBE IN PT. CATHETER OF NEEDLE BROKE OFF INTO TISSUE OF ABDOMINAL WALL. ADDITIONAL INFORMATION WAS RECEIVED 13-JUL-2023 STATING, "A 5 CM PIECE WAS RETAINED IN THE ABDOMINAL WALL." ADDITIONAL INFORMATION WAS RECEIVED 22-JUL-2023 STATING, "THE PATIENT REQUIRED A SURGERY TO HAVE THAT PIECE REMOVED" AND WAS SENT TO THE INTENSIVE CARE UNIT (ICU).

  Patient problems: Foreign Body In Patient

  MAUDE report 17278246 ↗
• MalfunctionJun 29, 2023Break; Break

  IT WAS REPORTED THE "PATIENT WENT TO ENDOSCOPY FOR PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) INSERTION. ON INSERTION OF PEG TUBE PATIENT COUGHED AND THE INTRODUCER WAS PULLED INTO THE ABDOMINAL CAVITY. MEDICAL DOCTOR (MD) TRIED TO RETRIEVE THE INTRODUCER BUT WAS ONLY ABLE TO REMOVE THE WHITE PART OF THE INTRODUCER. THE HUB PART WAS LEFT INSIDE ABDOMINAL WALL."

  Patient problems: Foreign Body In Patient

  MAUDE report 17226150 ↗
• MalfunctionJun 5, 2023Break; Break

  IT WAS REPORTED "A GASTROENTEROLOGIST WAS ATTEMPTING TO PLACE A PEG [PERCUTANEOUS ENDOSCOPIC GASTROSTOMY] WHEN THE TROCAR CATHETER MIGRATED INTO THE PATIENT¿S SOFT TISSUE, BECOMING IRRETRIEVABLE EXTERNALLY. IN ATTEMPT TO MOVE THE TROCAR CATHETER BACK OUT OF THE SOFT TISSUE, THE PHYSICIAN USED THE GASTROSCOPE AND A SNARE TO PUSH THE TROCAR FROM INSIDE. WHEN THEY DID THIS, THE TROCAR BROKE. THE TROCAR WAS THEN LODGED IN THE SOFT TISSUE AND UNABLE TO BE RETRIEVED ENDOSCOPICALLY. A GENERAL SURGEON WAS CONSULTED, AND THE PATIENT IS GOING TO THE OR [OPERATING ROOM] THIS MORNING TO REMOVE THE TROCAR CATHETER FROM THE SOFT TISSUE. THE CATHETER WAS NOT ABLE TO BE REMOVED IN THE ENDOSCOPY LAB. THE PATIENT WAS TAKEN TO THE OR BY A GENERAL SURGEON. INITIALLY, THE PATIENT WAS TO BE TAKEN TO THE OR ON THE SAME DAY OF THE EVENT, BUT AFTER A COMPUTED TOMOGRAPHY(CT) SCAN WAS PERFORMED POST ATTEMPTED PEG PLACEMENT AND IT WAS DECIDED TO TAKE THE PATIENT TO THE OR THE PREVIOUS NIGHT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17064815 ↗
• MalfunctionFeb 24, 2023Difficult to Remove; Material Too Rigid or Stiff; Difficult to Remove; Material Too Rigid or Stiff

  IT WAS REPORTED, THE PHYSICIAN EXPERIENCED DIFFICULTY WITH THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) KIT REMOVAL.; AN UNSUCCESSFUL ATTEMPT TO REMOVE IT, VIA TRACTION METHOD, WAS PERFORMED ON (B)(6)2023. IT WAS SUCCESSFULLY REMOVED VIA ENDOSCOPY WITHOUT FURTHER INCIDENT; THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16439973 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3006646024-2023-00010 FOR THE SECOND REPORT. IT WAS REPORTED, SEVERE TISSUE DAMAGE TO THE ESOPHAGUS OCCURRED, WHICH CAUSED BLEEDING PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) KIT. ADDITIONAL INFORMATION RECEIVED ON 03 FEB 2023 REPORTED, A LARGE SCRAPE OCCURRED WHEN THE TUBE AND WIRE WERE BROUGHT DOWN THE ESOPHAGUS AND INTO THE STOMACH. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 16414996 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3006646024-2023-00009 FOR THE FIRST REPORT. IT WAS REPORTED, SEVERE TISSUE DAMAGE TO THE ESOPHAGUS OCCURRED, WHICH CAUSED BLEEDING WHEN USING THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) KIT. NO MEDICAL INTERVENTION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 03FEB2023 REPORTED, THE PERFORATION OF THE ESOPHAGUS OCCURRED ON (B)(6) 2022, WHICH WAS REPAIRED BY ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PATIENT WAS REPORTEDLY STABLE WITH NO FURTHER PATIENT INCIDENCES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16414995 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K924065. One submission often covers many models, so check the product and lot details in each record.

• Z-2347-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catalog Number: 8170-14 Product Description: Feeding Tube Kit Comp
• Z-2346-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
• Z-2348-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20
• Z-2343-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feeding Tube Kit Component: No
• Z-2342-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit Component: No
• Z-2350-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14
• Z-2349-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24
• Z-2344-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
• Z-2345-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20
• Z-2341-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feeding Tube Kit
• Z-2352-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
• Z-2351-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20
• Z-0566-2022 · Dec 22, 2021 · Terminated
  MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
• Z-0565-2022 · Dec 22, 2021 · Terminated
  MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL