Z-1993-2013Class II

Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the...

Name: Z-1993-2013 Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the...
Creator: Cardiogenesis Corporation
Published: 2011-05-01
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2011-05-01 / Terminated / root cause: design

FDA source

Cardiogenesis Corporation began a recall of Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the treatment of patients with angina (Canadian... on 2011-05-01. FDA classified it as Class II and gives the reason as "Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1993-2013
Classification: Class II
Status: Terminated
Initiated: 2011-05-01
Posted: 2013-09-11
Terminated: 2014-09-15
Recalling firm: Artivion, Inc.
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.
Product code: MNO System, Laser, Transmyocardial Revascularization
Reason for recall: Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces.
Root cause tag: design
FDA root cause: 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
Product codes and lots: Product Code - HP-SG3 Product Code -HP-PRL5

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1993-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1993-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-11

Product code MNO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)