Santa Clara, Calif.-based Cordis first recalled five lots of the Powerflex Pro device in Sept. 6, 2018, after a supplier said they didn’t meet an internal specification for shaft burst strength.
Although those lots have since been taken off the market, on August 23 the company said its supplier notified it of three additional lots that don’t meet specs (although the devices do meet their labeled pressure requirement of 18 ATM, the company said).
“The lots were previously not identified by the manufacturer and were discovered by follow-up investigation,” Cordis said.
No reports of injury or death have surfaced due to the issue, according to the company, which noted that the risks from a shaft leakage or burst during balloon inflation could result in a procedural delay and, rarely, in damage to healthy intima, vessel spasm, ischemia or additional intervention.
“There is no safety concern for patients that are treated successfully using product from these lots,” Cordis said.