The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Precise PRO Rx US Carotid System
- Product and Lot numbers: Full List of Affected Devices
- Manufacturing Dates: October 2019 to August 2020
- Distribution Dates: December 6, 2019 to February 8, 2021
- Devices Recalled in the U.S.: 7,300
- Date Initiated by Firm: February 11, 2021
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.
Reason for Recall
Cordis Corporation 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.
Who May be Affected
- Health care providers using the affected Cordis device
- Patients who have procedures with the affected Cordis device
What to Do
On February 11, 2021, 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 to: GMBCordisFieldAction@cardinalhealth.com
- 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
Customers who have questions about the notification should contact their local sales representative or Cordis QA at: GMB-FieldCorrectiveActionp@cardinalhealth.com or call (786) 313-2087.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.