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U.S. Department of Health and Human Services

Class 2 Device Recall Cardiogenesis Transmyocardial the SoloGrip III (HP5G3) and the PEARL 5.0 (HPPRL5).

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  Class 2 Device Recall Cardiogenesis Transmyocardial the SoloGrip III (HP5G3) and the PEARL 5.0 (HPPRL5). see related information
Date Initiated by Firm May 01, 2011
Date Posted September 11, 2013
Recall Status1 Terminated 3 on September 15, 2014
Recall Number Z-1993-2013
Recall Event ID 66046
Product Classification System, laser, transmyocardial revascularization - Product Code MNO
Product Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser.

The device is indicated for use in the treatment of patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium with reversible ischemia not amenable to direct coronary revascularization.
Code Information Product Code - HP-SG3 Product Code -HP-PRL5
Recalling Firm/
Manufacturer		 Cardiogenesis Corporation
1655 Roberts Blvd NW
Kennesaw GA 30144-3632
For Additional Information Contact
949-420-1800
Manufacturer Reason
for Recall		 Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces.
FDA Determined
Cause 2		 Device Design
Action Cardiogenesis is responsible for the correction of all noncompliant products. CDRH understands that the corrective action plan (CAP), involving 2,437 Sologrip III handpieces and 61 PEARL 5.0 handpieces, consists of the following: 1. Notification to purchasers of the handpiece removal and replacement procedures, 2. Replace existing hospital inventory of handpieces with a redesigned handpiece CDRH approves the CAP subject to the following conditions: 1. Notification of all distributors and purchasers will be successfully implemented, and 2. Corrections will be made at no cost to the purchasers by October 1, 2013. For further questions please call (949) 420-1800.
Quantity in Commerce 2498
Distribution US Distribution
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.
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