Dive Brief:
- The Food and Drug Administration posted an early alert about an issue with Calyxo’s CVAC aspiration systems linked to one death.
- The alert, which the FDA published Thursday, describes a problem that can lead to excessive pressure in the kidney during procedures to remove urinary stones.
- Calyxo sent updated instructions for use to healthcare providers to mitigate the risk on Feb. 19. The FDA issued its alert under a pilot for providing early notice of potentially high-risk issues.
Dive Insight:
Calyxo received 510(k) clearance for a redesigned CVAC system one year ago. The system consists of a sterile single-use, steerable ureteral catheter and a reusable software-controlled image processor used to remove kidney stones, fragments and dust. Calyxo redesigned the device in light of real-world experience in the years after it received clearance for an earlier version in 2020.
The early alert lists the model number and unique device identifier of the newer product. The older product has a different model number and UDI.
Calyxo wrote to customers after identifying a new risk of injury during use of the CVAC aspiration system. Patients with thick fluid in the kidney at the start of the procedure can experience reduced fluid outflow, leading to excessive pressure in the organ. Unless addressed, the increased pressure can cause serious injury or death.
The company has updated its instructions to advise urologists to stop providing fluid inflow when fluid outflow is slow or absent. When physicians see cloudy, opaque or suspected thick fluid in the kidney’s collecting system, Calyxo has recommended they stop irrigation immediately using the stopcock. The system should not be used when the collecting system is completely obscured by opaque fluid.
The FDA is currently reviewing information about the potentially high-risk device issue and has asked healthcare providers to check its early alert webpage for updates. The agency plans to keep the public informed as significant new information becomes available.
