Class 2 Device Recall CardiAssist

• Date Initiated by Firm: April 09, 2009
• Date Posted: July 07, 2009
• Recall Status: Terminated on August 27, 2012
• Recall Number: Z-1582-2009
• Recall Event ID: 52223
• 510(K)Number: K050172
• Product Classification: circulatory assist device - Product Code DRN
• Product: Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device, Series 4000.
• Code Information: CardioAssist Model 4000 Serial 4018
• FEI Number: 2025845
• Recalling Firm/ Manufacturer: Cardiomedics Incorporated; 7 Whatney; Suite B; Irvine CA 92618-2839
• For Additional Information Contact: 949-863-2500
• Manufacturer Reason for Recall: Cuff may underinflate, or device may stop working during use. Cardioassist software version 4.3.1 utilized a signal from the plethysmograph that was found not to be sensitive enough due to the shape of the waveform in certain circumstances where there was excessive motion artifact.
• FDA Determined Cause: Software design
• Action: Service visit to customer in May 2009 to upgrade and validate CardioAssist 4000 software to version 4.3.5.
• Quantity in Commerce: 1
• Distribution: Florida
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DRN