Medtronic Recalls Parietex Composite Parastomal Mesh Due to Failure Reports
Medtronic is voluntarily removing Parietex Composite Parastomal Mesh from the market after receiving reports of product failure leading to hernia recurrence.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device failure leading to hernia recurrence and additional surgery, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported as a direct acute trauma but requires medical intervention.
Plain-English summary
Medtronic is voluntarily removing Parietex Composite Parastomal Mesh (Product Numbers PCOPM15 and PCOPM20) from the market. The recall follows reports of mesh failure identified several years after patients underwent parastomal hernia repair using the modified Sugarbaker technique. The product is a circular mesh made from polyester fabric with a hydrophilic film, indicated for the reinforcement of soft tissues during surgical repair.
The firm received a total of ten reports worldwide over the last five years regarding mesh failure. In these cases, the product failure resulted in hernia recurrence, which required additional surgical treatment. Symptoms of hernia recurrence can include discomfort, localized bulging (pain-free or painful), and changes in the overlying skin.
Patients who have received this specific 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.
The recalled product
- Product
- 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…
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Surgical Mesh
- Affected units
- 7,333
Distribution
Distributed nationwide across the United States.
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