Atherectomy system recalled due to sheath flaw

Candace Stuart | | Cardiovascular Business | Vascular & Endovascular

The FDA placed a Class I recall on the Diamondback 360 Peripheral Orbital Atherectomy System because the sheath may fracture during use.

St. Paul, Minn.-based Cardiovascular Systems issued a warning letter in late May to alert customers that some lots of the devices may contain defective saline sheaths. The system is a high-speed cutting tool for treating calcified plaque in patients who are candidates for percutaneous transluminal angioplasty. If fractured, the sheaths may result in an embolism.

Cardiovascular Systems reported no injuries to patients related to the sheaths. The 94 affected devices were manufactured between May 8 and 9 of this year, with 48 devices distributed between May 16 and 20. Lot numbers are 100573, 100575, 100674, 100676, 100678 and 100680 with the model number DPB-125MICRO145, part number 7-10003.

Affected devices should be returned to the manufacturer and any related adverse events reported to the FDA.

Candace Stuart, Contributor

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