Iradimed Notifies Potential Issue With Certain Syringe Adapter Sets During Use

Iradimed Corporation (NASDAQ:IRMD) notified a potential issue with some 1057 Syringe Adapter Sets related to the syringe venting function during use.…
  • Iradimed Corporation (NASDAQ:IRMD) notified a potential issue with some 1057 Syringe Adapter Sets related to the syringe venting function during use.
  • The company designs, manufactures, markets, and distributes MRI-compatible medical devices, accessories, disposables, and related services.
  • The issue can lead to reduced flow with the MRidium infusion pump resulting in subsequent inlet occlusion and alarm indication. 
  • The 1057 Syringe Adapter Set is an IV fluid administration set with a vented syringe adapter (disposable tubing), which allows for the delivery of IV fluids from syringes while on the company’s infusion pump.
  • Also Read: Iradimed Withdraws FDA Application For Updated MR IV Pump System.
  • The customer notification, which outlines the potential risks associated with the 1057 Syringe Adapter Set, lists the affected products. 
  • The updated labeling provides specific actions users should take to identify any venting and infusion delivery issues before an unexpected inlet occlusion occurs.
  • Iradimed received five customer complaints of an unexpected inlet occlusion alarm resulting in the infusion being stopped, none of which were associated with injuries or death. 
  • Upon investigation, the company identified a defective injection molded part that can limit the effectiveness of the syringe vent and result in this condition in an estimated 0.4% of recently manufactured 1057 infusion sets.
  • No other of the company’s IV sets or disposables are involved, and the company does not expect any material financial impact from this action.
  • Price Action: IRMD shares closed higher by 0.16% at $37.48 on Friday.
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