Marlborough, MAWhile allegedly defective medical devices such as the IVC filter have commanded major play in the press of late, the relatively quiet recall of Defective Catheters Causing Injury back in the spring appears to have slipped under the radar. However the risk is no less compelling. Millions of the devices have been recalled, including 21,000 units of The Fetch 2 Aspiration Catheter manufactured by Boston Scientific Corp (Boston Scientific).
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.
Then, this past April, Cook Medical took the final step of recalling all lots of devices in its catheter line. “We’ve been investigating a variety of factors including environmental influences and it’s been difficult for us to reproduce the exact failures that our customers have experienced,” said Pete Yonkman, president of Cook Medical and Cook Group, in a statement posted on the official Cook Medical web site. “If we cannot tell our customers how to keep our products safe, then we aren’t comfortable leaving them on the market. It’s a risk we’re not willing to take. Patient safety comes first – period.”
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.
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