FDA announces class 1 recalls for premixed embolic, infusion pump software

Editor's Note

The US Food and Drug Administration has classified recalls of Boston Scientific’s Obsidio Conformable Embolic and Fresenius Kabi USA’s Ivenix Infusion System Large Volume Pump (LVP) software as class 1, the most serious category and an indicator of risk of serious injury or death.

No injuries or deaths have been reported for the software, which is used with the Ivenix Infusion System for administering fluids. To remedy “anomalies” with the potential to cause serious harm or death, the manufacturer will release a new software version. Fresenius Kabi sent reportedly all affected customers an Urgent Medical Device Field Correction on March 7.

Seven injuries and two deaths have been associated with Obsidio Embolic, a premixed embolic agent recalled due high risk of bowel ischemia when delivered via the aliquot technique—common in embolization procedures—for lower gastrointestinal (GI) bleeding embolization. This method may prevent blood and oxygen flow to the small bowel (ischemia) or other organs, necessitating prolonged hospitalization or surgery such as bowel resection and/or diverting colostomy. The manufacturer recommends against using the aliquot technique to deliver the agent for lower GI bleed embolization.