Navina™ Smart Control Unit 69014Recalls & reported problems
Wellspect AB · Navina Smart Transanal Irrigation. 1 Navina Smart control unit with power adapter and cable. Non Sterile Device. Rx Only. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07333387028729), received between Aug 22, 2025 and May 11, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Product Quality Problem
A NURSE REPORTED THAT THE SMART SYSTEM DID NOT ACCOUNT CORRECTLY FOR THE VOLUME OF FLUID DELIVERED TO THE PATIENT. SPECIFICALLY, THE USER OBSERVED THAT WHEN THE CONTAINER WAS FILLED TO APPROXIMATELY 650 ML AND THE SYSTEM WAS SET TO DELIVER 400 ML, THE CONTAINER BECAME EMPTY WHILE THE DEVICE DISPLAY INDICATED THAT ONLY APPROXIMATELY 0.3 L HAD BEEN DELIVERED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25133874 ↗MalfunctionAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A USER OF THE NAVINA SMART ELECTRONIC CONTROL UNIT, USED IN CONJUNCTION WITH THE NAVINA SMART TRANSANAL IRRIGATION SYSTEM AND RECTAL BALLOON CATHETER, REPORTED RECURRING FUNCTIONAL ISSUES DURING USE. SPECIFICALLY, THE USER EXPERIENCED REPEATED OCCURRENCES OF ERROR CODES 501 AND 502 AT VARIOUS TIMES DURING IRRIGATION SESSIONS. ACCORDING TO THE USER, THE DEVICE BECOMES UNRESPONSIVE DURING THESE EPISODES AND CANNOT BE POWERED OFF MANUALLY. THE SYSTEM MUST BE LEFT TO FULLY DISCHARGE BEFORE IT CAN BE RESTARTED. THESE MALFUNCTIONS OCCUR WHILE THE RECTAL BALLOON IS INFLATED, PREVENTING NORMAL DEFLATION VIA THE SYSTEM. AS A RESULT, THE USER MUST MANUALLY DISCONNECT ALL TUBING IN ORDER TO REMOVE THE CATHETER FROM THE RECTUM. A REPLACEMENT NAVINA SMART UNIT WAS SHIPPED TO THE USER AND CONFIRMED DELIVERED ON AUGUST 12. NO INJURIES OR MEDICAL INTERVENTIONS WERE REPORTED. THE AFFECTED DEVICE WAS NOT RETURNED, AND THE LOT NUMBER COULD NOT BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22870599 ↗
Other Enema kit devices
- Navina™ Smart System Regular 69009Wellspect AB · Enema kit2 reports
- Navina™Consumable Set Small 69004Wellspect AB · Enema kit1 report
- Navina™ Classic System Small 69007Wellspect AB · Enema kit1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page