The Recall Desk
SevereFDA (Devices)·Z-1993-2013·Announced 2013-09-18

Cardiogenesis Transmyocardial Laser Recalled Due to Sparks and Burns

Cardiogenesis Corporation is recalling 2,498 Transmyocardial Laser devices due to reports of sparks, burns, or smoke incidents.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves reports of burns, which aligns with the rubric criterion for significant injury reports.

Plain-English summary

Cardiogenesis Corporation is recalling 2,498 units of the Cardiogenesis Transmyocardial Laser. The device is indicated for the treatment of patients with angina refractory to medical treatment and secondary to coronary artery atherosclerosis. The recall covers units distributed in the US.

The recall was initiated following the acquisition of Cardiogenesis, during which the company began receiving complaints regarding the device's handpieces. These complaints specifically cited incidents involving sparks, burns, or smoke.

Healthcare providers and patients should stop using the affected devices immediately. The recall is classified as Class II by the FDA.

The recalled product

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 atheros
Manufacturer
Cardiogenesis Corporation
Category
Medical Device — Surgical Laser
Hazard
Affected units
2,498

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Product Code - HP-SG3 Product Code -HP-PRL5

Distribution

Distribution scope not specified by the agency.

Related recalls

Same hazard · burn injury

See all →