URGENT MEDICAL DEVICE RECALL

October 8, 2010

To: Covidien (Confluent Surgical, Inc) Customers

    Subject:

  • Recall PleuraSeal™ Lung Sealant System
  • Product Catalog Number – PLS-005

This letter is to inform you that Covidien is conducting a voluntary medical device recall of all lots of Confluent Surgical, Inc, PleuraSeal™ lung sealant system. This action is being undertaken due to the unanticipated interim results of an Investigational Device Exemption (IDE) study. This study that was being conducted in the United States to evaluate the safety and efficacy of PleuraSeal ™ lung sealant system in the treatment and control of intra and post-operative air leaks following pulmonary resection via an open thoracotomy. Interim results of this study showed a higher than anticipated persistent air leak rate and inconsistent efficacy. Prolonged air leaks may increase the risk of patient complications and can result in prolonged hospital stay and/or medical intervention. Please be advised, based on these results and in addition to this recall, the IDE study has been terminated and Covidien has elected to discontinue commercial availability of this product.

Please assess your inventory and immediately quarantine all units of PleuraSeal™ lung sealant system. Please return all affected product according to the following directions. You will receive credit for the returned units.

  • Please contact Covidien Customer Service to request a Return Material Authorization (RMA). Covidien will arrange for shipment pickup and will cover all freight costs associated with return of affected units.

Please note, this voluntary recall is limited to PleuraSeal™ lung sealant system and does NOT affect Covidien products. Your Covidien representative will be available to provide additional assistance should you require it.

We apologize for any inconvenience this may have caused and thank you for your business and continued support. If you have any questions or concerns, please do not hesitate to contact your Covidien Representative or Covidien Quality Assurance at 1-203-492-5232.

Sincerely,

  • Sandra L. DePonte
  • Director, Quality Compliance