While no injuries had been reported in association with The Fetch 2 Aspiration Catheter as of April 11, the recall nonetheless was identified as a Class 1 recall by the US Food and Drug Administration (FDA), the most serious of all recall classifications available to the federal regulator.
A Class 1 recall suggests serious risk from a medical device, including injury and death.
The Fetch 2 Aspiration Catheter is manufactured by Boston Scientific, which released a statement at the time of the Class 1 recall with regard to the potential for “shaft breakage” of a device commonly used in surgical procedures and designed to remove blood clots.
“While unreported, the most severe potential outcome of this breakage is embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment surgically,” Boston Scientific said in its statement.
Boston Scientific may not have had this problem two years ago, when it had yet to acquire the interventional device division of Bayer AG for $415 million. However, that purchase was finalized in May of 2014, and with it liability for The Fetch 2 Aspiration Catheters, which were acquired from Bayer in the deal.
Boston Scientific isn’t the only player in the troubled catheter arena. Cook Medical, as it turns out, was one of the first to issue recalls when problems began to surface with regard to its Beacon line of catheters. Cook, in fact, recalled various lots of its Beacon catheters last year amidst increasing complaints of breakage or shattering of catheter tips, which were found to split or fracture.
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Among the catheters recalled by Cook Medical were all lots of their Shuttle Select Slip-Catheter line.
Legal pundits are musing that lawsuits will begin to flow as this portfolio gains more traction, as would-be plaintiffs come to realize that their health may have been compromised by the breakage or failure of allegedly defective catheters before they were recalled from the market.