Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Recalled by Covidien LLC Due to The firm is issuing this voluntary removal following...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Covidien LLC directly.
Affected Products
Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional monofilament polyester fabric with a two-dimensional monofilament polyester central band. One side of the design is completely covered with the hydrophilic film. On the opposite side, only the two-dimensional central band is coated with the absorbable hydrophilic film. The film extends 5 mm over the external edge of the reinforcement. The Parietex composite parastomal mesh is indicated for the reinforcement of soft tissues during surgical repair, and specifically for the repair of parastomal hernias. The non-absorbable polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera.
Quantity: 7333
Why Was This Recalled?
The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker repair technique. In these reports, product failure led to hernia recurrence requiring additional surgical treatment. Symptoms of hernia recurrence may include discomfort, localized pain-free or painful bulging, and possible changes in the overlying skin. Medtronic has received, worldwide, a total of ten reports of mesh failure following use of the product in the last five years. Patients who have received a Parietex" composite parastomal mesh for the treatment of a parastomal hernia should continue to receive ongoing monitoring by their healthcare providers for the recurrence of a parastomal hernia.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Covidien LLC
Covidien LLC has 248 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report