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Terminated

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.

FDA Recall Z-0461-2019 · Posted None

Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeFTL
Date Initiated2018-10-05
Date Terminated2020-05-07
Product Quantity7333

Reason for Recall

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.

Firm Action

On October 5, 2018, the firm notified its customers of the product issue via Urgent Medical Device Voluntary Removal. Required Actions: 1. Please quarantine and discontinue use of the affected item codes. 2. Complete the Product Return Form even if you do not have inventory. If no inventory, fax to 203-492-7719 or email [email protected]. 3. If purchased directly from Medtronic, fax the return form to 800-895-6140 or email [email protected]. Ship affected product with RGA# provided by customer service to: Medtronic Attn: Field Returns Department 195 McDermott Road North Haven, CT 06473 USA 4. If purchased from a distributor, contact distributor directly to arrange for return of product. Fax completed form to 203-492-7719 or email [email protected]. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

Worldwide distribution--US Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081126PARIETEX COMPOSITE MONO PM MESHSofradim Production · 2008-08-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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