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Terminated

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.

FDA Recall Z-1993-2013 · Posted 2013-09-11

Recalling FirmCardiogenesis Corporation
Recall StatusTerminated
Product CodeMNO
Date Initiated2011-05-01
Date Terminated2014-09-15
Product Quantity2498

Reason for Recall

Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces.

Firm 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.

Root Cause

Device Design

Distribution Pattern

US Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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