Urgent Field Safety Notice issued for Convatec Esteem Body™ Soft-Tap Convex Urostomy Pouches

Convatec has issued an Urgent Field Safety Notice, dated July 2026, concerning selected batches of its Esteem Body™ Soft-Tap Convex Urostomy Pouches. The manufacturer is voluntarily carrying out a Field Safety Corrective Action after identifying that a limited subset of products may not perform as intended, potentially resulting in leakage.

The affected units were distributed between 19 September 2025 and 12 May 2026.

What has been identified?

Through complaint handling and post-market surveillance, Convatec identified an increasing trend in complaints and began an internal investigation.

The investigation identified variability in the Soft-Tap interference fit – the sealing interface between the plug and the tap/stem – in a limited subset of Esteem Body™ Soft-Tap Convex Urostomy Pouches. This may lead to leakage from the Soft-Tap cap during use.

Reported instances have primarily occurred following connection to a night drainage system, where the plug-to-tap seal may be compromised. The Field Safety Notice provides further details on how to identify affected products and how to check whether the Soft-Tap continues to function correctly.

What is the potential risk?

Leakage from the Soft-Tap cap may result in skin irritation, interruption of therapy, the need to replace the product, inconvenience, property damage, and other consequences associated with unintended leakage.

Convatec reports that it has received 90 complaints associated with leakage of affected products. Based on the information available to the manufacturer, no serious injuries have been reported in connection with these complaints.

Which products are affected?

The Field Safety Notice applies only to specified product codes and lot numbers of Esteem Body™ Soft-Tap Convex Urostomy Pouches.

Other Esteem Body™ products are not affected, including urostomy batches not identified in the notice, Drainable pouch variants, and Closed-End pouch variants.

The complete list of affected UK product codes and lot numbers, together with information to help identify affected products, can be found in the Field Safety Notice.

What actions are required from distributors, wholesalers, clinical facilities, and hospitals?

Organisations should check their inventory against the affected product and lot numbers listed in the Field Safety Notice.

Any affected products identified should be quarantined, and their distribution, sale, transfer, and use discontinued.

Organisations that have supplied or transferred affected products should notify relevant customers and consignees, provide them with the Field Safety Notice, and instruct them to follow the required actions.

Recipients of the notice are also instructed to complete and return the acknowledgement form provided by Convatec. Where affected stock is identified, Convatec will provide a Certificate of Destruction for completion.

What actions are required from patients and end users?

Patients and end users should check their supplies against the affected product and lot numbers listed in the Field Safety Notice.

If affected products are identified, users should discontinue their use and contact their supplier, healthcare provider, or Convatec representative to obtain replacement products as soon as possible.

Where a replacement is not immediately available and continued use is necessary, Convatec provides temporary precautionary instructions for checking for leakage after disconnecting the Soft-Tap from a night drainage system or leg bag. These interim measures are temporary and do not replace the need to obtain replacement products as soon as possible.

What actions are required from sales representatives?

Sales representatives are instructed to stop all sales, distribution, and promotion of affected products, and not to supply affected stock to customers.

They should review personal stock, consignment stock, demonstration kits, and customer-held inventory where they have visibility, identify affected lot numbers, and dispose of affected products.

Sales representatives should also notify affected end users within their territory using the approved Field Safety Notice, without modifying its wording.

They are also instructed to complete the Response Form and Certificate of Destruction provided by Convatec.

Passing on the notice

The Field Safety Notice should be shared with all relevant people within affected organisations and with any external organisations to which potentially affected products have been supplied or transferred.

Device-related incidents or complaints should be reported to the manufacturer, distributor, or local representative through the appropriate reporting channels.

Further information

Distributors, wholesalers, healthcare organisations, patients, sales representatives, and other affected users should review the full Convatec Field Safety Notice for full product identification information, required actions, and instructions for checking the Soft-Tap seal.

For replacement products or general enquiries in the UK, contact Convatec:

Telephone: 01244 284882
Email: Uk.customerservice@convatec.com

For questions relating specifically to the Field Safety Corrective Action, email fsca-id@convatec.com.