The FDA has issued an early alert regarding a potential safety issue with Calyxo’s CVAC Aspiration System, warning that improper use can lead to serious injury or death.
On Feb. 19, Calyxo notified healthcare providers about updated instructions for use after identifying a risk of kidney pressure imbalance when patients have thick fluid in the kidney, according to a March 20 news release from the FDA.
The company advised providers to immediately stop irrigation if fluid outflow slows or stops, as continued inflow can dangerously increase kidney pressure. Additional precautions include ensuring proper equipment setup and avoiding use in patients with untreated infections or certain medical conditions.
There has been one reported death related to the issue, the release said.
