Navina™ Classic System Small 69007 (REF 6900740)Recalls & reported problems
Wellspect AB · Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube set, 2 Rectal catheters small, 1 Accessory set, 1 Navina case. 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07392532243714), received between Feb 23, 2026 and Feb 23, 2026 — classified as 1 injury.
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
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED A REPORT INVOLVING A NAVINA CLASSIC SMALL RECTAL CATHETER IN WHICH THE CAREGIVER (MOTHER) INADVERTENTLY INSERTED THE RECTAL CATHETER INTO THE PATIENT'S VAGINA INSTEAD OF THE RECTUM AND INFLATED THE BALLOON WITH TWO PUMPS. WHEN THE BALLOON WAS DEFLATED, THE PATIENT EXPERIENCED ACTIVE VAGINAL BLEEDING AND WAS TAKEN TO THE EMERGENCY ROOM. AT THE HOSPITAL, THE PATIENT UNDERWENT AN EXPLORATORY DIAGNOSTIC PROCEDURE TO ASSESS FOR POSSIBLE UTERINE INJURY. NO UTERINE PERFORATION WAS IDENTIFIED, NO SURGICAL INTERVENTION WAS REQUIRED, AND THE PATIENT WAS MONITORED, TREATED FOR PAIN, AND DISCHARGED. THE PATIENT SUBSEQUENTLY COMPLETED A NAVINA IRRIGATION AT THE HOSPITAL WITHOUT ISSUE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24412751 ↗
Other Enema kit devices
- Navina™ Smart Control Unit 69014Wellspect AB · Enema kit2 reports
- Navina™ Smart System Regular 69009Wellspect AB · Enema kit2 reports
- Navina™Consumable Set Small 69004Wellspect 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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