HEART VALVE RECALL ALERT: Serious Recall for Heart Valve
HEART VALVE RECALL ALERT:
On January 2, 2018, the FDA issued a Class I recall – the most serious type of recall – for the Agilis Steerable Introducer Sheath devices made by the company Sterilmed. This device is a hemostatic valve which prevents blood from flowing back through the valve. According to the FDA, the valve may fail due to an improper seal of the sheath hub. Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism). This product defect may cause serious health consequences in patients, including death.
The model and lot numbers are as follows:
– Model numbers and lot numbers: STJ408309, STJ408310, STJG408324; All product lots
– Manufacturing and Distribution Dates: January 1, 2017 to May 5, 2017
Patients should check your operative report and surgery records to determine whether they have this valve implanted. As of now, the FDA is recommending that doctors continue to monitor patients with this valve. However, this may change as information becomes more readily available. The FDA recall can be found here.
Injuries caused by heart devices are serious and not to be taken lightly. This heart valve is under the strictest device recall because it may cause serious injury or death. I worked on many heart device litigations in the past, including the Guidant heart device litigation where my client testified before the Senate Judiciary Committee and the House of Representatives in support of the Medical Device Safety Act (which Congress chose not to enact). Watch here. You should investigate immediately to determine whether you have been affected by this heart valve recall.
If you have the Agilis Steerable Sheath valve implanted, please contact Claudine Homolash, Esq. at firstname.lastname@example.org or (215) 510-2245 for a free legal consultation.