Class 1 Recall: Boston Scientific Corporation, Chariot Guiding Sheath May Break off During the Procedure
Class 1 Recall: Boston Scientific Corporation, Chariot Guiding Sheath May Break off During the Procedure
Tue Jan 05 2016
Class 1 Recall: Boston Scientific Corporation, Chariot Guiding Sheath May Break off During the Procedure
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.
Recalled Device
- Chariot Guiding Sheath
- All unit product numbers (UPNs)
- Manufacturing Dates: March 17, 2015 to November 10, 2015
- Distribution Dates: June 6, 2015 to November 17, 2015
- Devices Recalled in the U.S.: 5,692 units Nationwide
Device Use
The Chariot Guiding Sheath is used to guide the placement of interventional and diagnostic devices into the veins and arteries of a patient’s arms, hands, legs or feet (peripheral vasculature).
Reason for Recall
Boston Scientific has received fourteen complaints of the shaft of the device separating. This can cause small pieces to break off the device and enter the patient’s bloodstream. This could obstruct blood flow and require additional interventions to remove device fragments. Obstructed blood flow can result in serious patient injuries such as stroke, kidney damage, damage to the intestines or limbs, or can cause patient death.
Who may be affected?
- Health care providers using the Chariot Guiding Sheath
- All patients who may be undergoing peripheral vascular procedures
What to Do
On December 15, 2015 Boston Scientific sent an Urgent Medical Device Recall Removal letter to their customers. In the letter they instructed customers to:
- Immediately stop using any affected products
- Quarantine affected products
- Complete the enclosed Reply Verification Tracking Form (RVTF) and fax it to 866-213-1806 (Attn: Field Action Center) or email to BSCFieldActionCenter@bsci.com
- Return affected devices as directed by Boston Scientific.
Contact Information
Physicians and health care facilities with questions can contact their Boston Scientific representative or call 1-800-811-3211.
Date Recall Initiated
November 19, 2015
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 either online, by regular mail or by FAX.