Medtronic Perfusion Systems has issued a critical recall for approximately 101,010 DLP Left Heart Vent Catheters because the devices may fail to maintain their intended shape during surgical use. The recall affects models 12110, 12113, and 12115, which are used to vent or drain the left heart during cardiac procedures. Medtronic is initiating this voluntary recall via a notification letter to affected healthcare facilities to address the risk of the catheters becoming malleable and losing their form.
If the catheter does not retain its shape, it may fail to drain the heart properly or lead to internal injury to the patient during a surgical procedure. Given the critical nature of cardiac surgery, any malfunction of the vent catheter could result in serious patient harm.
Quantity: 34,549 units.
Quantity: 41,200 units.
Quantity: 25,261 units.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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