Recall Z-1959-2012— Cardiovascular Systems, Inc.

Name: FDA recall Z-1959-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-18

Class II · Terminated

Class II FDA medical device recall by Cardiovascular Systems, Inc., initiated 2012-06-18, terminated 2012-07-19. It names one FDA 510(k) clearance: K110389. Product: CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. The Stealth 360-degree Orbital PAD system is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.. Reason: CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the driveshaft..

Recalling firm: Cardiovascular Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-06-18
Terminated: 2012-07-19
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K110389 — STEALTH 360 ORBITAL PAD SYSTEMCardiovascular Systems, Inc.·cleared 2011-03-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. The Stealth 360-degree Orbital PAD system is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

Reason for recall

CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the driveshaft.

Data sourced from openFDA. This site is unofficial and independent of the FDA.