FDA MedWatch – Precise PRO Rx US Carotid System by Cordis:

TOPIC: Precise PRO Rx US Carotid System by Cordis: Class I Recall – Due to Risk of Separation in Device During Use

AUDIENCE: Patient, Health Professional, Risk Manager

ISSUE: Cordis is recalling their Precise PRO Rx US Carotid System because of a risk of separation of the atraumatic distal tip of the sheathed delivery system in patients. If the device separates during use this may cause serious adverse events such as removal of the separated tip from the carotid artery, embolization distally, or stroke.

There have been 7 complaints, including 5 reported injuries about this device issue. No deaths have been reported.

For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND: The Precise PRO Rx US Carotid System is used to treat patients with narrowed carotid arteries. The system includes a metal (nitinol) self-expanding stent preloaded on a delivery catheter used to place the stent.

RECOMMENDATIONS: On February 11, 2020, Cordis Corporation sent an Urgent Medical Device Recall letter to all affected customers and provided the following instructions:

• Read the Urgent Medical Device Recall letter
• Immediately check your inventory to confirm that you do not have any units from the affected lots in your possession
• Identify and set aside any units from the identified lots in a manner that ensures the affected product will not be used
• Check all storage and usage locations
• Review, complete, sign and return the Acknowledgement Form enclosed in the Urgent Medical Device Recall letter to Cordis at the fax number on the form or email provided in the recall 
• Return any affected product to the address listed on the form, with reference to your Customer Number which is listed on the form
• Share this letter with others in your facility who need to be made aware of this recall
• Contact any other facility that may have been sent the affected units of PRECISE PRO RX Carotid Stent System from your facility
  • If any units of the affected lots are found to be at the other facility, please arrange the return of the units
• Maintain awareness of this notice until all affected product has been returned to Cordis
• Keep a copy of this notice with the affected product until returned

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.