Class 1 Recall Notice
The Food and Drug Administration along with ev3 Endovascular, Inc. has announced a Class I recall of Trailblazer Support Catheters.
The defective devices have the potential to crack and injure patients when inserted into a vein to deliver liquids to a patient.
The area with the potential to crack lies near the radiopaque marker band, according to the FDA. When that occurs, patients can receive insufficient oxygen supply to the tissues, which can lead to limb amputation, heart attack, and death.
Physicians had reported the incidents to the FDA during what the company calls “the initial limited market release of the device in the U.S.”
See the specific model numbers on the FDA’s Web site. The catheter were made from September 11, 2009 through September 29, 2009 and distributed up until October 27, 2009.
ev3, Inc. is based in Plymouth, Minnesota and can be contacted at 1-800-716-6700.
In all eight models and 27 lots of the Trailblazer catheter were recalled under Class 1 which means there is “reasonable probability that use of these products will cause serious adverse health consequences or death.”
While the FDA disclosed the voluntary recall Tuesday, it was actually initiated in November 2009.
In a statement issue today, the company says that a voluntary Class 1 recall has been completed and all affected units are in the company’s possession. No other ev3 devices were involved in the action, the company says.
"It's my understanding that the problem's been fixed and they're shipping new catheters," said Thomas Gunderson, an analyst with Piper Jaffray & Co. tells the Minneapolis Star Tribune. He added that recalls "are a part of standard operations at medical device companies.''
Riegel And Defective Device Litigation
Patients injured or survivors of patients killed by defective medical devices are prevented from suing the manufacturer under a 2008 U.S. Supreme Court decision.
In February 2008, Riegel v. Medtronic affirmed medical device makers have a shield from litigation.
The Medical Device Safety Act of 2009 would overturn the Riegel decision and allow patients to pursue injury recovery in court. The last Congressional hearings were held in August 2009 and the proposal failed to make it out of committee.
See the models here:
Product Name: Trailblazer Support Catheter
SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, SC-035-150.
7828282, 7792290, 7792584, 7805570, 7805797, 7806392, 7820252, 7790666, 7791887, 7803307, 7835331, 7822400, 7822593, 7800446, 7800555, 7800756, 7800779, 7800809, 7801822, 7801875, 7803305, 7803306, 7820273, 7834779, 7834845, 7824905, 7832205.