A Flexi-Seal is a medical device that diverts and contains liquid stool by routing it through a soft tube inserted into the rectum and into a sealed collection bag. Made by ConvaTec, it’s used in hospitals and long-term care facilities for patients with prolonged diarrhea who are bedridden or immobile, particularly when loose stool threatens to break down surrounding skin or contaminate wounds.
How the Device Works
The full name is the Flexi-Seal Fecal Management System, and it has four main components: a soft silicone catheter, a small retention balloon near the tip, a syringe for inflating that balloon, and a privacy collection bag with an odor-filtering system. A clinician inserts the catheter into the rectum, then inflates the balloon with water (typically 30 to 45 milliliters, never exceeding 45) to hold it gently in place. The catheter connects to the collection bag, which hangs on the bedside below the level of the patient so gravity moves waste downward.
The bag includes a filter designed to neutralize odor and can be emptied or replaced without removing the catheter itself. A cinch clamp on the tubing lets nurses temporarily stop flow when changing the bag or repositioning the patient.
Who Needs One
Flexi-Seal devices are most commonly used for critically ill or immobile patients dealing with frequent, uncontrollable liquid or semi-liquid stool. The typical scenarios include patients in intensive care units, people recovering from major surgery, and those with severe diarrhea caused by infections, tube feeding, or medications. It’s especially useful when a patient already has pressure injuries, surgical wounds, or burns near the buttocks, because constant contact with liquid stool can rapidly worsen skin breakdown and increase infection risk.
The device is not designed for formed stool. It works only when output is liquid enough to flow through the catheter on its own.
How Long It Can Stay In
The FDA has cleared the Flexi-Seal for up to 29 days of continuous use. In practice, nursing teams assess the device daily to check for leakage, skin irritation around the insertion site, and proper balloon positioning. The balloon’s fill level is monitored using a green indicator on the inflation port. If the indicator pops at less than 30 milliliters of water, the catheter may need to be repositioned within the rectal vault before re-inflating.
Skin Protection and Infection Control
One of the primary reasons hospitals use fecal management systems is to protect fragile skin. In a clinical study of 42 patients, skin integrity was either maintained or improved in more than 92% of patients while the device was in place. Minimal or no leakage was reported in 83% of nearly 200 daily assessments.
The sealed system also reduces the risk of spreading infections through the environment. In laboratory testing, researchers challenged Flexi-Seal devices with high concentrations of Clostridioides difficile (a bacteria that causes severe, contagious diarrhea) over a 31-day period. C. diff was never recovered from the outside surface of any device, and air samples taken near the devices were also free of contamination. By contrast, absorbent underpads used as a comparison allowed the contaminated liquid to wick sideways beyond the pad’s edges, a common route for spreading bacteria to bedding and surrounding surfaces.
What It Feels Like for the Patient
Most patients report mild discomfort during insertion, which takes only a few minutes. Once the balloon is inflated and the catheter is secured, many patients describe a sensation of fullness in the rectum that fades over time. The device eliminates the need for repeated cleaning and repositioning that comes with traditional incontinence care, which can be painful for patients with raw or broken-down skin. For patients who are alert, the privacy bag and odor filter also reduce the social discomfort of uncontrolled diarrhea in a shared hospital room.
Possible Complications
The most common problems are minor: leakage around the catheter, irritation at the insertion site, and the balloon deflating or shifting out of position. These are usually resolved by repositioning or replacing the device.
More serious complications are rare but documented. Prolonged use can cause bleeding or pressure damage to the rectal lining from the retention balloon pressing against tissue. In one published case, a patient developed a severe narrowing (stricture) at the junction of the rectum and sigmoid colon after extended use. The narrowing was too tight to be opened with a scope, and the patient ultimately required surgical removal of the affected bowel segment with creation of a colostomy. While this outcome is extremely uncommon, it underscores why nursing teams monitor the device daily and remove it as soon as the patient’s diarrhea resolves or slows enough to manage with other methods.
How It Compares to Other Options
Before fecal management systems existed, the standard approach for bedridden patients with liquid stool was absorbent pads, barrier creams, and frequent cleaning. This works for mild cases but becomes unsustainable with high-volume diarrhea, often requiring skin care every one to two hours and still resulting in breakdown. Rectal tubes (simple catheters without a balloon) were sometimes improvised but lacked a reliable way to stay in place and frequently leaked.
The Flexi-Seal fills the gap between these basic measures and surgical options like a colostomy. It’s a temporary, non-surgical solution that keeps stool entirely contained within a closed system while the underlying cause of diarrhea is treated.