The U.S. Food and Drug Administration (FDA) just announced that Cardiovascular Systems is recalling some lots of its Diamondback 360 Peripheral Orbital Atherectomy Systems.
The agency has deemed this recall a Class I, its most serious type of recall designation and one that involves situations in which a reasonable probability that use of the recalled product may cause serious adverse health consequences, or death.
The recalled Diamondback 360 Peripheral Orbital Atherectomy Systems involved in this recall include model number DPB-125MICRO145; Part number 7-10003. The involved lot numbers are: 100573, 100575, 100674, 100676, 100678, 100680.
The recall was put it place because the recalled devices might contain defective saline sheaths that might fracture during use. Should this occur, fragments of the sheath might potentially block blood vessels (embolism). To date, no patient injuries have been reported.
The Diamondback 360 Peripheral Orbital Atherectomy System is a high-speed cutting tool that is inserted by catheter through the skin and into a patient’s blood vessel. The system is meant to re-establish blood flow in narrowed arteries or arterio-venous dialysis shunts.
The device is meant for patients who are considered acceptable candidates for procedures to open up blocked blood vessels using catheters with balloons, which is also known as percutaneous transluminal angioplasty.
From May 9, 2014 to May 9, 2014, a total of 94 of the devices were manufactured. Of these, 48 devices were distributed from May 16, 2014 to May 20, 2014.
On May 27, 2014, Cardiovascular Systems sent an “Urgent Medical Device Recall” letter to its customers. The recall letter described the issue and the specific products that are impacted by this recall. The letter also advised Cardiovascular Systems customers to:
- Remove the recalled Diamondback 360 Peripheral Orbital Atherectomy Systems from service.
- Complete and return the enclosed “Customer Acknowledgement Form.”
- Return the recalled Diamondback 360 Peripheral Orbital Atherectomy Systems to Cardiovascular Systems. Cardiovascular Systems’ Customer Service Department may be reached, toll-free, at 1-877-274-0901.