Navina™Consumable Set Small 69004Recalls & reported problems
Wellspect AB · Navina Transanal Irrigation. Consumable set small. 1 Water container, 15 Rectal catheters small. Non Sterile device. Rx Only. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07333387025506), received between Mar 12, 2026 and Mar 12, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping 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
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Bowel Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2026Manufacturing, Packaging or Shipping Problem
A FOREIGN INCIDENT OCCURRED OUTSIDE THE UNITED STATES AND WAS LIMITED TO A SINGLE COUNTRY. A CUSTOMER ORDERED A NAVINA SMALL RECTAL CATHETER INTENDED FOR TRANSANAL IRRIGATION BUT RECEIVED A NAVINA REGULAR RECTAL CATHETER INSTEAD. THE DISCREPANCY WAS IDENTIFIED PRIOR TO USE; THE CATHETER WAS NOT USED AND WAS RETURNED TO THE MANUFACTURER.
Patient problems: Bowel Perforation
MAUDE report 24578523 ↗
Other Enema kit devices
- Navina™ Smart Control Unit 69014Wellspect AB · Enema kit2 reports
- Navina™ Smart System Regular 69009Wellspect AB · Enema kit2 reports
- 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.
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