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| Quest Medical's MPS delivery set--Courtesy of Quest Medical |
Quest Medical has recalled delivery sets for its perfusion device for open heart surgeries after the company discovered issues with seals for the product that could lead to patient blood loss.
The Allen, TX-based company voluntarily initiated certain lots of delivery sets for its Myocardial Protection System (MPS) after it got 20 complaints about a possible seal failure along the blood source channel of the main pump cassette, resulting in 16 cases of patients losing blood during surgery. The problem could also interrupt drug delivery, Quest said in its recall notice.
The company has already notified the FDA and customers about the problem, and there have not been any reports of patient injuries related to the potential seal failure to date, it added. Quest is also notifying distributors and customers with a letter and plans to return or replace the recalled product, the company said in its notice.
A recall could spell big trouble for Quest, which is trying to gain traction for its MPS system. The device contains spline-piston pumps and pressure sensors that perfusionists and doctors use to deliver whole blood or cardio drugs to the heart during open heart surgery.
Quest is not the only one trying to make waves with its drug-delivery cardiac technology. Earlier this year, Svelte Medical reeled in $16 million to dial up marketing for its transradial cardiac stent. The device, which is smaller and less invasive than traditional drug-eluting stents, can be inserted through an artery in the wrist instead of through the groin, offering an advantage over current technology.
- here's Quest Medical's recall notice