AVANOS 40-9438Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00350770460505), received between Dec 22, 2022 and Jul 1, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Material Puncture/Hole

  THE CUSTOMER REPORTED THAT WHILE ADMINISTERING ASPIRIN THROUGH THE NASOGASTRIC FEEDING TUBE, MEDICATION LEAKED THROUGH HOLES IN THE SIDE OF THE TUBING. THE HOLES WERE LOCATED OUTSIDE THE PATIENT. THE TUBE WAS REPLACED, AND A FOLLOW-UP X-RAY WAS PERFORMED. NO OIL-BASED MEDICATIONS OR MCT OIL WERE USED.

  Patient problems: Insufficient Information

  MAUDE report 25678207 ↗
• MalfunctionJun 18, 2026Material Rupture

  IT WAS REPORTED THAT A NASOJEJUNAL (NJ) TUBE BECAME BLOCKED DURING USE AND SPLIT OPEN NEAR THE PATIENT¿S EAR DURING FLUSHING ATTEMPTS, RESULTING IN LEAKAGE OF FORMULA AND REQUIRING REMOVAL AND REPLACEMENT OF THE TUBE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25552579 ↗
• MalfunctionJun 3, 2026Leak/Splash; Material Puncture/Hole; Difficult to Remove

  IT WAS REPORTED THAT A GUIDEWIRE WAS DIFFICULT TO REMOVE, EVEN AFTER LUBRICATING. IN ADDITION, THE NASOGASTRIC TUBE WAS FOUND TO BE LEAKING CLOSE TO THE END PORT, OUT OF MULTIPLE SMALL HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25382169 ↗
• MalfunctionMay 26, 2026Material Rupture

  IT WAS REPORTED THAT A NASOGASTRIC TUBE BURST CLOSE TO THE MEDICATION PORT WHEN GIVING MEDICATIONS. NO INJURIES REPORTED. EVENT DATE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279080 ↗
• MalfunctionApr 13, 2026Break

  IT WAS REPORTED VIA FDA MEDSUN UF/IMPORTER REPORT (B)(4), THE USER FACILITY REPORTED THAT DURING A HYPERTENSIVE EPISODE, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND IMAGING (KIDNEY, URETER, BLADDER X-RAY) REVEALED THAT THE NASOGASTRIC TUBE WAS BROKEN WITHIN THE STOMACH. THE TUBE HAD BEEN IN PLACE FOR LESS THAN 30 DAYS. DURING A GASTROINTESTINAL PROCEDURE, THE NASOGASTRIC TUBE WAS IDENTIFIED AS RUPTURED BUT NOT DISCONNECTED AND WAS REMOVED IN ITS ENTIRETY UNDER DIRECT VISUALIZATION. THE ESOPHAGEAL AND GASTRIC MUCOSA WERE REPORTED AS WITHIN NORMAL LIMITS. A NEW NASOGASTRIC TUBE WAS PLACED AND POSITION WAS CONFIRMED VIA IMAGING. THE EVENT OCCURRED IN FEBRUARY 2026.

  Patient problems: Foreign Body In Patient

  MAUDE report 24865130 ↗
• MalfunctionApr 3, 2026Complete Blockage

  AVANOS MEDICAL 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 9611594-2026-00170 FOR THE FIRST EVENT. REFER TO 9611594-2026-00174 FOR THE SECOND EVENT. IT WAS REPORTED "THE FEEDING PUMP READ OCCLUDED. NURSE WAS UNABLE TO FLUSH THE [NASOJEJUNAL] NJ FEEDING TUBE. TUBE WAS REMOVED...THESE TUBES ARE USUALLY KEPT IN PLACE FOR UP TO 30-DAYS. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778405 ↗
• MalfunctionApr 3, 2026Complete Blockage

  AVANOS MEDICAL 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 9611594-2026-00170 FOR THE FIRST EVENT. REFER TO 9611594-2026-00175 FOR THE THIRD EVENT. IT WAS REPORTED "THE FEEDING PUMP READ OCCLUDED. NURSE WAS UNABLE TO FLUSH THE [NASOJEJUNAL] NJ FEEDING TUBE. TUBE WAS REMOVED...THESE TUBES ARE USUALLY KEPT IN PLACE FOR UP TO 30-DAYS. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778404 ↗
• MalfunctionApr 3, 2026Complete Blockage

  AVANOS MEDICAL 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 9611594-2026-00174 FOR THE SECOND EVENT. REFER TO 9611594-2026-00175 FOR THE THIRD EVENT. IT WAS REPORTED "THE FEEDING PUMP READ OCCLUDED. NURSE WAS UNABLE TO FLUSH THE "[NASOJEJUNAL]" NJ FEEDING TUBE. TUBE WAS REMOVED AND REPLACED WITH ANOTHER 8 FR CORFLOW FEEDING TUBE. UPON REMOVAL, NURSE NOTICED A KINK IN THE FEEDING TUBE. NURSE HAD REPORTED THIS TUBE WAS PLACED YESTERDAY FOR THE SAME ISSUE (KINK IN THE TUBE AROUND THE SAME PLACE). THESE TUBES ARE USUALLY KEPT IN PLACE FOR UP TO 30 DAYS. THE PATIENT "IS RECEIVING CONTINUOUS FEEDINGS OF BREAST MILK (NOT FORTIFIED) AT 42 ML/HR. NO MEDICATIONS GIVEN RECENTLY." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778403 ↗
• InjuryOct 1, 2025Break; Break

  IT WAS REPORTED THE "NJT [NASOJEJUNAL TUBE WAS] BLOCKED SINCE 0600. ATTEMPTED TO UNBLOCK WITH ENZYMES AS PER POLICY AT 1230 WITH NO LUCK, MET WITH...RESISTANCE AND CAUSING A NOTICEABLE AMOUNT OF DISCOMFORT TO PATIENT. PATIENT THEN TAKEN TO STAT ULTRASOUNDS TO RULE OUT INTUSSUSCEPTION AS PER NP (NURSE PRACTIONER). ONCE BACK IN ROOM AT APPROXIMATELY 1500 PATIENT IRRITABLE AND SNEEZING, [THE REPORTER] ATTEMPTED TO NASAL TIP SUCTION THE SECRETIONS/SNOT AROUND NOSE AND NJT. NJT BEGAN POKING OUT NEAR THE NARE/NASAL BRIDLE (SECUREMENT DEVICE), AT CLOSER LOOK WRITER NOTED THE NJ TUBING APPEARED TO BE TORN/SPLIT OPEN; NP NOTIFIED AND CAME IN ROOM TO ASSESS. BRIDLE THEN CUT BY WRITER AND AS THE NJT WAS BEING REMOVED THE TUBE BROKE INTO 2 PIECES, BUT BOTH PIECES BEING ABLE TO BE FULLY REMOVED FROM PATIENT. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 08-SEP-2025 NOTED THE TUBE WAS IN PLACE FOR 10-DAYS (INSERTED AUGUST 15 AND REMOVED AUGUST 25). THE PATIENT WAS RECEIVING CONTINUOUS FEEDINGS RUNNING AT 40ML/HOUR FOR 18-HOURS. NONE OF THE FEEDINGS CONSISTED OF BLENDED FEEDS NOR THICK CONSISTENCY FORMULAS. ORAL AND CRUSHED MEDICATIONS WERE USED IN THE DEVICE. THERE WERE NO OILS N

  Patient problems: Foreign Body In Patient

  MAUDE report 23193046 ↗
• MalfunctionAug 18, 2025Burst Container or Vessel; Difficult to Flush; Obstruction of Flow

  B [BACKGROUND]: HAS HAD MULTIPLE FEEDING TUBES WITH CLOGGING ISSUES. LAST TUBE PLACED IN IR [INTERVENTIONAL RADIOLOGY] ON [DATE REDACTED]. ON [DATE REDACTED] - APPROXIMATELY 2.5 WEEKS AFTER LAST FEEDING LINE WAS PLACED, RN NOTED FEEDING PUMP ALARMING, UNABLE TO FLUSH ND [NASODUODENAL] TUBE, MD NOTIFIED. CONTRAST GIVEN AT BEDSIDE AND FOUND TUBE DISRUPTED WITH CONTRAST FILLING STOMACH, PROXIMAL PART OF TUBE IN STOMACH AND DISTAL PART OF TUBE IN DUODENUM. A: UNINTENTIONALLY RETAINED FOREIGN OBJECT. PER UNIT CNS [CLINICAL NURSE SPECIALIST], TUBE WAS MANAGED PER STANDARDS. WHEN MEDS ADMINISTERED, CRUSHED, DILUTED, FLUSHED APPROPRIATELY, USE OF "CLOG ZAPPER" WHEN NOTED TUBE FLUSHING SLUGGISHLY. OF NOTE PATIENT DOES NOT RECEIVE MANY MEDS THROUGH TUBE, LAST MED ADMINISTERED 3 HOURS PRIOR TO CLOGGING EPISODE. R: CONTINUE TO FOLLOW STANDARD CRUSHING, DILUTING, FLUSHING GUIDELINES WHEN ADMINISTERING MEDS. TO IR TOMORROW FOR REMOVAL OF RETAINED TUBE AND PLACEMENT OF ND TUBE. THE NGT [NASOGASTRIC TUBE] DEVICE BURST OPEN WHILE IN PLACE. PART OF THE NGT WAS RETAINED IN THE PATIENT'S STOMACH. VISCOUS FEEDS ARE LIKELY CLUMPING UP IN THE NGT. THE NGT BURST WHILE INSIDE THE PATIENT. THE TUBE WAS CLOG

  Patient problems: Foreign Body In Patient

  MAUDE report 22827361 ↗
• MalfunctionFeb 26, 2025Break; Obstruction of Flow; Break; Obstruction of Flow

  IT WAS REPORTED, "PATIENT'S FEEDING PUMP ALARMED WITH CLOGGED LINE AND UPON ASSESSMENT, BEDSIDE NURSE DECIDED TO ATTEMPT DECLOTTING LINE. FIRST WITH ENFIT 35 ML SYRINGE BUT WAS INEFFECTIVE SO UPON SUGGESTION OF CHARGE RN, USED A 5 ML SYRINGE WITH SODA ATTEMPTED BUT UPON ATTEMPT TO FLUSH, HEARD A POP INSIDE PATIENT'S NOSTRILS. IN ATTEMPT TO DISCONTINUE DOBHOFF AND PULL NG OUT, ONLY A FEW CM'S WAS PULLED OUT AND THE REST OF THE TUBE STILL INSIDE PATIENT. DR IN MICU TEAM MADE AWARE. CNS AIDED WITH USING TONGUE DEPRESSOR TO ASSESS PATIENT'S THROAT AND USING A CHEST TUBE CLAMP, WAS ABLE TO RETRIEVE AND PULL OUT THE REST OF THE REMAINING DOBHOFF TUBE FROM PATIENT'S THROAT."

  Patient problems: Foreign Body In Patient

  MAUDE report 21470071 ↗
• MalfunctionJun 25, 2024Stretched; Obstruction of Flow; Material Split, Cut or Torn; Stretched; Obstruction of Flow; Material Split, Cut or Torn

  IT WAS REPORTED,¿ PRN [AS NEEDED] MEDICATION WAS BEING ADMINISTERED THROUGH THE NASOGASTRIC (NG) TUBE AND THERE WAS RESISTANCE FELT IN TUBE. TUBE WAS ABLE TO BE FLUSHED WITH EXTRA FORCE. PATIENT THEN PULLED TUBE OUT ABOUT SHORTLY AFTER. TUBE WAS FOUND TO HAVE A BUBBLED AREA WITH A SPLIT IN THE TUBE TOWARDS THE END OF THE TUBE.¿ NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19605889 ↗
• MalfunctionJun 17, 2024Material Twisted/Bent; Unintended Movement; Material Split, Cut or Torn; Material Twisted/Bent; Unintended Movement; Material Split, Cut or Torn

  IT WAS REPORTED VIA FDA REPORT (B)(4),¿ PATIENT HAD NEW FREQUENT EMESIS DURING DAYSHIFT AND AT THE CHANGE OF SHIFT HE CONTINUED TO HAVE MORE EMESIS, COLOR WAS CLEAR/OPAQUE, VOLUME WAS LARGE AT THE START OF SHIFT. REGISTERED NURSE (RN) PAUSED THE FEEDS. HIS NASOJEJUNAL TUBE (NJT) CAME OUT ABOUT TWO INCHES OUT HIS NOSE; RN RE-TAPED THE NJT TUBE. RN UPDATED THE PROVIDER REGARDING THE EMESIS AND HOW IT SMELLED SLIGHTLY LIKE FORMULA AND ASKED TO ORDER A KIDNEY, URETER, AND BLADDER (KUB) X-RAY. PATIENT CONTINUED TO BE UNCOMFORTABLE AND FREQUENTLY COUGHED, GAGGED AND VOMITED, WHICH BECAME GREEN IN COLOR AND LESS VOLUME. AFTER THE MDS VIEWED THE KUB, THERE SEEMED TO BE A KINK IN THE TUBE AND SO DECIDED TO REMOVE THE NJT. AFTER RN REMOVED IT, NJT WAS FULLY INTACT; HOWEVER, AT THE KINK THERE WAS THINNING OF THE NJT AND AN OPEN SLIT; MDS WERE NOTIFIED. PATIENT FELT MUCH MORE COMFORTABLE AND STOPPED COUGHING AND GAGGING AFTER NJT REMOVED. PER MD, PATIENT TO TRANSITION TO IV MEDS AND IV FLUIDS FOR THE NIGHT. PRODUCT HAD KINK WITH WEAKENED TUBE INTEGRITY, PRODUCT DISPOSED.¿.

  Patient problems: Cough; Vomiting

  MAUDE report 19546560 ↗
• InjuryMar 12, 2024Break; Break

  IT WAS REPORTED VIA FDA USER REPORT (B)(4) THE FOLLOWING INFORMATION: PATIENT WITH NEW ONSET TACHYCARDIA UP TO 180-190S WHILE CALM, OCCASIONALLY INTO THE 200'S (MAX HEART RATE 210), WHO INITIATED THE RRT (RAPID RESPONSE TEAM). BACKGROUND: 22 MONTHS-OLD MALE ADMITTED WITH RESPIRATORY SYNCYTIAL (RSV) BRONCHIOLITIS AND EAT (ECTOPIC ATRIAL TACHYCARDIA). NASOJEJUNAL TUBE (NJ) IN PLACE FOR MEDS AND FEEDS. ASSESSMENT: PATIENT BASELINE HR 110'S-120'S WHILE IN PEDIATRIC INTENSIVE CARE UNIT (PICU) AND INITIALLY DURING FIRST 10-15 ON UNIT, ABRUPT INCREASE WITH PERSISTENT HR > 180. PATIENT ALSO ON ENTERAL FEEDS WHERE NJ WAS NOTED TO BE TAPED DUE TO BROKEN/LOOSE CONNECTION AND UPON ASSESSMENT WAS LEAKING FEEDS AND LIKELY MEDICATION. LAST DOCUMENTED DOSE OF SOTALOL WAS [TIME REDACTED] IN PICU PRIOR TO PATIENT TRANSFERRING TO PCU 300. THIS DOSE OF SOTALOL LIKELY NEVER REACHED THE PATIENT DUE TO MALFUNCTIONING TUBE, LEADING TO ECTOPIC ATRIAL TACHYCARDIA (EAT). REGISTERED RESPIRATORY THERAPIST (RRT) CALLED WITHIN 5 MINUTES OF RSN BEING CALLED TO ROOM BY BEDSIDE RN AND RSN IDENTIFYING EAT. REQUESTED A STAT EKG AND IVF. RECOMMENDATION: TRANSFER TO ICU TO RESOLVE EAT WITH EITHER IV MEDICATION OR PLACE

  Patient problems: Tachycardia

  MAUDE report 18887798 ↗
• MalfunctionOct 5, 2023Break; Break

  IT WAS REPORTED "POST-PYLORIC DOBHOFF [THE] TUBE BROKE DURING MEDICATION ADMINISTRATION". THE TUBE WAS BRIDLED SO AFTER IT BROKE THE REMAINING PIECE OF TUBING WAS REMOVED FROM PATIENT WITHOUT INCIDENT. ADDITIONALLY, "THIS IS A PATIENT THAT IS ON HIGH RESPIRATORY SUPPORT THAT THE TEAM RECOGNIZES WILL NOT TOLERATE REPLACING THE POST-PYLORIC TUBE. CONTINUOUS FEEDS NEEDED TO BE DISCONTINUED AND ENTERAL MEDICATIONS RE-ROUTED THROUGH NG [NASOGASTRIC] TUBE. NG IS A SALEM SUMP WHICH IS NOT A RECOMMENDED DEVICE FOR LONG-TERM ADMINISTRATION BUT NECESSARY FOR THIS PATIENT SITUATION."

  Patient problems: Foreign Body In Patient

  MAUDE report 17876322 ↗
• MalfunctionFeb 13, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT WHEN THE NURSE PULLED THE NASOJEJUNAL (NJ) TUBE OUT OF THE PATIENT, IT WAS BROKEN INTO TWO PIECES (IT WAS CONNECTED BY THE PLASTIC MATERIAL THAT HAD BALLOONED); THE BROKEN PORTION WAS NOT NOTICED UNTIL AFTER REMOVAL. NO HARM REACHED THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16369028 ↗
• MalfunctionDec 22, 2022Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED 22DEC2022 REPORTED, THE TUBE WAS PLACED ON (B)(6) 2022 AND WAS REMOVED ON (B)(6) 2022; THE TUBE INTEGRITY WAS NOTICED ON AN X-RAY. THE SYRINGE SIZE USED FOR SMALL CHILDREN WAS NO MORE THAN 10MLS; ALL OF THE MEDS WERE LIQUID.

  Patient problems: Feeding Problem

  MAUDE report 16040068 ↗