To Get Help Now
Click Here
 
Today's Date:

Defective Saline Sheaths Prompt Recall of Atherectomy Systems

AddThis Social Bookmark Button

The U.S. Food and Drug Administration (FDA) announced that Cardiovascular Systems is recalling certain lots of the Diamondback 360 Peripheral Orbital Atherectomy Systems because they contain defective saline sheaths that could fracture during use.

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

If a saline sheath fractures during use, fragments could block blood vessels.

The affected Diamondback 360 Peripheral Orbital Atherectomy Systems have the model number DPB-125MICRO145 (Part number 7-10003) and the lot number 100573, 100575, 100674, 100676, 100678, or 100680.

Ninety-four of the recalled Diamondback 360 Peripheral Orbital Atherectomy Systems were manufactured from May 8, 2014, to May 9, 2014. The remaining affected systems were manufactured from May 16, 2014, to May 20, 2014.

Cardiovascular Systems issued an Urgent Medical Device Recall to its customers on May 27, instructing them to:

-Remove affected devices from service.
-Complete and return a Customer Acknowledgement Form.
-Return affected systems to the company.

Cardiovascular Systems also informed customers that they can receive additional information about the affected Diamondback 360 Peripheral Orbital Atherectomy Systems by calling 1-877-274-0901.

breakinglawsuitnews.com disclaimer: This article: Defective Saline Sheaths Prompt Recall of Atherectomy Systems was posted on Friday, August 22nd, 2014 at 2:05 pm at breakinglawsuitnews.com and is filed under Medical Device Lawsuits, Product Liability Lawsuits.

« »

Comments are closed.