NeoConnect Enteral Extension SetRecalls & reported problems across all models
Neomed, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 4 models of NeoConnect Enteral Extension Set by Neomed, Inc. in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, received between Nov 4, 2019 and Oct 21, 2020 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
NeoConnect Enteral Extension Set 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.
- Oct 24, 2018Terminated
The sterile pouch label states the expiration date is 2016-11-19, but the correct expiration date is 2019-11-09. The case label and the shipper label have the correct date
Z-0526-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported NeoConnect Enteral Extension Set problems
Device problems
- Fluid/Blood Leak5
- Leak/Splash4
- Crack2
- Defective Device1
Patient problems
- No Known Impact Or Consequence To Patient9
- Underdose1
NeoConnect Enteral Extension Set models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NeoConnect Enteral Extension Set EXT-60NCTubes, Gastrointestinal (And Accessories)1 recall0 reports
- NeoConnect Enteral Extension Set EXT-60YNCTubes, Gastrointestinal (And Accessories)5 reports
- NeoConnect Enteral Extension Set PEXT-60NCTubes, Gastrointestinal (And Accessories)3 reports
- NeoConnect Enteral Extension Set PEXT-60YNCTubes, Gastrointestinal (And Accessories)2 reports
Recent NeoConnect Enteral Extension Set adverse event reports
The 10 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2020Leak/Splash
WE ARE REPORTING TWO FAILURES OF THE SAME PRODUCT THAT HAPPENED WITHIN 1 WEEK OF EACH OTHER: ON (B)(6) 2020: THE FEEDING TUBING WAS FOUND TO HAVE LEAKED THE BABY'S FEEDING. AFTER THE FEEDING WAS COMPLETE AND THE PUMP TURNED OFF, THE BABY WAS FUSSY AND ACTING HUNGRY. IT WAS THEN DISCOVERED HIS LINENS SOAKED IN FORMULA UNDER THE TUBING AND NG CONNECTION. SOME FORMULA WAS MANUALLY PUSHED THROUGH THE TUBING AND IT WAS ALL LEAKING OUT OF A CRACK AT THE HUB. THE BABY WAS RE-FED THROUGH NEW TUBING THAT WAS NOT CRACKED OR LEAKING (LOT# 20200227). ON (B)(6) 2020: THE FEEDING TUBE (NEOCONNECT ENTERAL EXTENSION SET WITH ENFIT CONNECTOR LOT:20200110) LEAKED MEDOLAC FEED WHERE IT CONNECTS TO THE PATIENT'S NG TUBE WHEN BEING ADMINISTERED BY PUMP. THE HEALTH CARE PROVIDER CAUGHT THE LEAK EARLY SO ONLY A FEW ML WAS WASTED AND NEW TUBING WAS OBTAINED TO DELIVER THE REMAINDER OF THE PATIENT'S FEED.
Patient problems: Underdose
MAUDE report 10711138 ↗MalfunctionJul 15, 2020Leak/Splash; Defective Device
A TOTAL OF 22 DEFECTIVE NEOCONNECT 60" (152 CM) ENFIT EXTENSION SETS (PEXT-60NC) WERE FOUND BETWEEN MAY 18TH AND JUNE 15TH, 2020. THE TUBING SETS WERE FROM 4 DIFFERENT LOT NUMBERS, BUT THE SAME DI/PRODUCT/REFERENCE #S. THE DEFECTIVE LOTS WERE AS FOLLOWS: 20191126, 20191218, 20191230, AND 20200110. THE CAREGIVERS FOUND THE ENFIT FEEDING EXTENSION LEAKING AT THE PATIENT CONNECTION. ALL HAVE BEEN CHECKED TO MAKE SURE THEY WERE SECURED APPROPRIATELY WITH NO "TILTING" OR MISCONNECTION NOTED. ALSO THAT THEY WERE NOT "TOO TIGHT" OR "LOOSE". SOME HAVE BEEN NOTED TO BE CRACKED AT PATIENT SIDE SECUREMENT. ONCE WE HAD 2 EXTENSIONS THAT WERE COMPROMISED, WE IMMEDIATELY NOTIFIED OUR NURSING STAFF TO WATCH FOR OTHERS. BECAUSE OUR STAFF WAS AWARE, THEY HAVE BEEN ABLE TO CATCH THE LEAKS EARLY ON SO INFANTS RECEIVE THEIR FULL CALORIES AS ORDERED. THEY HAVE WORKED WITH MATERIALS TO PULL THOSE LOT NUMBERS AS DEFECTIVE BATCHES HAVE BEEN FOUND. ONLY FOUR PATIENTS ARE INCLUDED IN THIS REPORTS ALTHOUGH THERE WERE MORE AFFECTED. BREAKDOWN OF LOT #'S: 20191126 - 8 TOTAL. 20191218 - 3 TOTAL. 20191230 - 3 TOTAL. 20200110 - 1 TOTAL. UNKNOWN - 7 TOTAL (PACKAGING NOT SAVED BUT CONNECTION/TUBING WAS).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10275436 ↗MalfunctionFeb 21, 2020Crack; Leak/Splash
TUBING REPORTED TO BE LEAKING AT THE FEMALE HUB, LOOKS LIKE A HAIRLINE FRACTURE. RECURRING PROBLEM WITH THIS PRODUCT AT THIS FACILITY FOR APPROXIMATELY 5 MONTHS. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED; THE MANUFACTURER SAYS THEY ARE INVESTIGATING. THE PROBLEM CONTINUES TO OCCUR. THERE ARE MULTIPLE REPORTS FOR THIS ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9740407 ↗MalfunctionFeb 12, 2020Fluid/Blood Leak
LEAKING NOTED AT THE FEMALE HUB CONNECTOR, APPROXIMATELY HALF WAY THROUGH FEEDING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9699652 ↗MalfunctionFeb 12, 2020Fluid/Blood Leak
LEAKING NOTED AT THE FEMALE HUB CONNECTOR, APPROXIMATELY HALF WAY THROUGH FEEDING. RECURRING PROBLEM WITH THIS PRODUCT AT THIS FACILITY FOR APPROXIMATELY 5 MONTHS. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED; THE MANUFACTURER SAYS THEY ARE INVESTIGATING. THE PROBLEM CONTINUES TO OCCUR. THERE ARE MULTIPLE REPORTS FOR THIS ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9699624 ↗MalfunctionFeb 12, 2020Fluid/Blood Leak
LEAKING NOTED AT THE FEMALE HUB CONNECTOR, APPROXIMATELY HALF WAY THROUGH FEEDING. RECURRING PROBLEM WITH THIS PRODUCT AT THIS FACILITY FOR APPROXIMATELY 5 MONTHS. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED; THE MANUFACTURER SAYS THEY ARE INVESTIGATING. THE PROBLEM CONTINUES TO OCCUR. THERE ARE MULTIPLE REPORTS FOR THIS ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9699623 ↗MalfunctionFeb 12, 2020Fluid/Blood Leak
TUBING LEAKING DURING INFANT FEEDING AT THE UNION OF TUBING AND MALE HUB. RECURRING PROBLEM WITH THIS PRODUCT AT THIS FACILITY FOR APPROXIMATELY 5 MONTHS. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED; THE MANUFACTURER SAYS THEY ARE INVESTIGATING. THE PROBLEM CONTINUES TO OCCUR. THERE ARE MULTIPLE REPORTS FOR THIS ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9699589 ↗MalfunctionFeb 12, 2020Leak/Splash
LEAKING BETWEEN CONNECTION FROM OROGASTRIC TUBE AND EXTENSION TUBING, AT THE FEMALE HUB. RECURRING PROBLEM WITH THIS PRODUCT AT THIS FACILITY FOR APPROXIMATELY 5 MONTHS. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED; THE MANUFACTURER SAYS THEY ARE INVESTIGATING. THE PROBLEM CONTINUES TO OCCUR. THERE ARE MULTIPLE REPORTS FOR THIS ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9699231 ↗MalfunctionFeb 12, 2020Crack
3 DIFFERENT FEEDING TUBE CONNECTORS CRACKED AT FEMALE HUB. RECURRING PROBLEM WITH THIS PRODUCT AT THIS FACILITY FOR APPROXIMATELY 5 MONTHS. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED; THE MANUFACTURER SAYS THEY ARE INVESTIGATING. THE PROBLEM CONTINUES TO OCCUR. THERE ARE MULTIPLE REPORTS FOR THIS ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9699221 ↗MalfunctionNov 4, 2019Fluid/Blood Leak
ON (B)(6) 2019 - ON TWO SEPARATE INCIDENCES OCCURRED (IN THE SPAN OF 24 HOURS) FOR PURPLE FEEDING EXTENSION TUBES LEAKING MILK ONTO THE BED AT THE CONNECTION BETWEEN THE END OF THE NG TUBE AND THE FEEDING EXTENSION TUBE. THERE WERE NO CRACKS OR HOLES SEEN IN THE TUBING AND THE CONNECTIONS SEEMED SECURE. THE CAUSE OF BOTH EVENTS ARE UNKNOWN, SO WE ARE TRACKING OCCURENCES TO HELP SPOT TRENDS. ON (B)(6) 2019 - DURING SHIFT HANDOFF AT 0600, INFANT ENFIT FEEDING TUBE ENTERAL EXTENSION SET WAS FOSUND TO BE LEAKING FORMULA AT PATIENT SIDE CONNECTOR WITH A MODERATE AMOUNT OF FORMULA NOTED ON BURP CLOTH. LEAKING WAS NOTED BY BOTH DAY AND NIGHT SHIFT RN'S. FEEDING EXTENSION SET WAS CHANGED AND FEEDING CONTINUED WITHOUT FURTHER LEAKAGE. ON (B)(6) 2019 - FEEDING LEAKING FROM EXTENSION SET. SECOND TIME THIS WEEK. THIS IS A REPLACEMENT PRODUCT DUE TO A BACK ORDER. ON (B)(6) 2019 - FEEDING EXTENSION TUBING LEAKED. ON (B)(6) 2019 - ENFIT FEEDING EXTENSION TUBING LEAKED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9271485 ↗
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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