FDA Medical Device Recalls (openFDA)
Cardiogenesis Corporation: 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.
- Recall number
- Z-1993-2013
- Recalling firm
- Cardiogenesis Corporation
- 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.
- Status
- Terminated
- Initiated
- 2011-05-01
- Posted
- 2013-09-11
- Terminated
- 2014-09-15
- Reason
- Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces.
- 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
- 2498
- Distribution
- US Distribution
- Lot, serial or model codes
- Product Code - HP-SG3 Product Code -HP-PRL5
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MNO
- Firm FEI
- 3001451326
- Firm city
- Kennesaw
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28