Boston Scientific, the state’s largest medical device company, has launched a product recall following reports that parts of its medical device broke off and lodged within some patients. Marlborough-based Boston Scientific said the recall of the Chariot Guiding Sheath is voluntary and was enacted three weeks ago, on Nov. 19. The Food and Drug Administration (FDA) has classified the move as a Class 1 recall, the most serious type which can lead to death or serious injury. The device is a long, hollow catheter through which even thinner devices can be inserted in medical procedures to diagnose or treat blockages of the blood vessels or other conditions.
The company says it has received 14 complaints in which the catheter’s shaft separated from the insertion device. Four of those separations occurred on the end that’s inserted into the patient’s body. No permanent injuries or patient deaths have been reported, the company said.
To date, there have been 21 reports regarding the company’s Chariot device on the FDA’s website concerning adverse events related to medical devices. Those results span from June 15 (shortly after the product was approved for use by the FDA on June 9) through Nov. 24. The company said in the statement:
The most severe outcome of this failure is embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment. Obstruction of blood flow can result in injuries such as stroke, kidney damage or damage to the intestines or limbs.
The recall appears to be the second this year for the company, after none for all of last year, according to the FDA’s list of recalls. The company recalled its RotaWire Elite Guidewire device in March. It’s used to open narrowed arteries. Parts of the wire can break off inside the patient. That recall was also classified at Class 1, and resulted in one patient death following a medical intervention to remove the broken wire, according to the FDA.
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