Cardiovascular Systems Recalls Atherectomy System Over Sheath Fracture Concerns
Cardiovascular Systems is recalling certain lots of its Diamondback 360 Peripheral Orbital Atherectomy Systems because they may contain defective saline sheaths that could fracture during use. The defect may lead to a blocked blood vessel, resulting in an embolism, according to a recall notice posted to the FDA’s website on Aug. 19.
The St. Paul, Minn., devicemaker sent an “Urgent Medical Device Recall” letter to its customers on May 27. The Class I recall includes lot numbers 100573, 100575, 100674, 100676, 100678 and 100680. The 94 affected devices were manufactured from May 8 to May 9, and 48 of them were distributed between May 16 and May 20.
Customers are advised to remove affected product from service, complete the company’s “Customer Acknowledgement Form” and return both the device and form to Cardiovascular Systems.
No patient injuries have been reported, the devicemaker said.
The Diamondback 360 Peripheral Orbital Atherectomy System is a high-speed cutting tool that is inserted into a patient’s blood vessel via a catheter. The device is designed to reestablish blood flow in narrowed arteries or arteriovenous dialysis shunts.
View the recall notice at www.fdanews.com/ext/resources/files/08/08-20-14-DiamondbackRecall.pdf. — Kellen Owings
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