Diamondback 360 Peripheral Orbital Atherectomy System by Cardiovascular Systems: Class I Recall - Sheath May Fracture During Use

[Posted 08/19/2014]

AUDIENCE: Cardiology, Risk Manager

ISSUE: Cardiovascular Systems is recalling certain lots of the Diamondback 360 Peripheral Orbital Atherectomy Systems, model number DPB-125MICRO145 (Part number 7-10003), because they may contain defective saline sheaths that could fracture during use. If this happens, fragments of the sheath could possibly block blood vessels. There are no reported patient injuries to date.

Affected lot numbers: 100573, 100575, 100674, 100676, 100678, 100680.

BACKGROUND: The Diamondback 360 Peripheral Orbital Atherectomy System is a high-speed cutting tool inserted via a catheter through the skin into a patient’s blood vessel. The system is used to reestablish blood flow in narrowed arteries or arterio-venous dialysis shunts.

Ninety-four affected devices were manufactured from 05/08/2014 to 05/09/2014.  Forty-eight devices were distributed from 05/16/2014 to 05/20/2014.

RECOMMENDATION: On May 27, 2014, Cardiovascular Systems sent an “Urgent Medical Device Recall” letter to their customers. The letter identified the problem and the specific products affected by the recall. The letter advises customers to:

• Remove affected devices from service.
• Complete and return a “Customer Acknowledgement Form.”
• Return affected devices to Cardiovascular Systems
• For more information, contact Cardiovascular Systems Customer Service at 1-877-274-0901.

[08/19/2014 - Recall Notice - FDA]