Cardiovascular Systems Diamondback 360 Peripheral Orbital Atherectomy System - Sheath May Fracture During Use
Recall Class: Class I
Date Recall Initiated: May 23, 2014
Product: Diamondback 360 Peripheral Orbital Atherectomy System
Model number: DPB-125MICRO145, Part number 7-10003.
Lot numbers: 100573, 100575, 100674, 100676, 100678, 100680.
Range of manufacturing and distribution dates: Ninety-four affected devices were manufactured from 05/08/2014 to 05/09/2014. Forty-eight devices were distributed from 05/16/2014 to 05/20/2014.
Use: The Diamondback 360 Peripheral Orbital Atherectomy System is a high-speed cutting tool inserted via a catheter through the skin into a patient’s blood vessel. The system is used to reestablish blood flow in narrowed arteries or arterio-venous dialysis shunts. It is intended for patients who are acceptable candidates for procedures to open up blocked blood vessels using catheters with balloons (percutaneous transluminal angioplasty).
Cardiovascular Systems, Inc. (CSI)
651 Campus Drive
Saint Paul, MN 55112-3495
Reason for Recall: Cardiovascular Systems is recalling certain lots of the Diamondback 360 Peripheral Orbital Atherectomy Systems because they may contain defective saline sheaths that could fracture during use. If this happens, fragments of the sheath could possibly block the blood vessel under treatment or blood vessels further away (cause an embolism). There are no reported patient injuries to date.
Public Contact: For information, contact Cardiovascular Systems Customer Service at 1-877-274-0901.
FDA District: Minneapolis District Office
More Information about this Recall:
On May 27, 2014, Cardiovascular Systems sent an “Urgent Medical Device Recall” letter to their customers. The letter identified the problem and the specific products affected by the recall. The letter advises customers to:
- Remove affected devices from service.
- Complete and return a “Customer Acknowledgement Form.”
- Return affected devices to Cardiovascular Systems.
About Class I Recalls
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.