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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- 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.
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