The MHRA has advised parents and carers not to use rectal catheters sold for personal use in infants to address colic, gas-related discomfort or constipation, and to dispose of unused devices.
The regulator says there is insufficient clinical evidence to demonstrate effectiveness and that the potential risks are unknown. Its notice identifies possible rectal trauma, bleeding, pain or perforation and warns that temporary symptom relief could delay diagnosis of serious gastrointestinal conditions.
The advice does not apply to rectal catheters used as part of specialist treatment for conditions such as Hirschsprung disease, meconium ileus or gastroschisis when parents or carers have been trained by healthcare professionals.
Anyone concerned about an infant should contact a healthcare professional rather than use these personal-use products. Device incidents can be reported to the MHRA through the Yellow Card scheme or the relevant local route.
