Dive Brief:
- Boston Scientific has recalled more than 1 million angiographic catheters distributed globally after receiving increased complaints about an inability to advance the guidewire through the device’s internal channel, according to a May 10 enforcement report from the Food and Drug Administration.
- The FDA cited evidence of the device’s polyurethane layer separating. Material in the catheter’s inner lining detached in some cases, the FDA said. Boston Scientific initiated the recall on March 21, and the agency posted the report on Friday.
- There is no risk to patients who have already been treated with the device, Boston Scientific said in an email to MedTech Dive. The company added that physicians have been given instructions for returning unused, potentially affected devices.
Dive Insight:
In a coronary angiogram, a common procedure to detect blockages in blood vessels, flexible tubes called catheters are inserted into an artery and guided to the heart.
The recalled devices are certain Expo 5Fr Angiographic Catheters used for diagnosis in percutaneous coronary intervention procedures, Boston Scientific said in its email.
“Our internal investigation identified evidence of the inner polymer layer of the catheter separating from other layers and, in some instances, this material detaching inside the device,” Boston Scientific wrote.
The FDA labeled the recall as a Class I event, the most serious classification.
Boston Scientific asked hospitals to isolate and discontinue use of any recalled products in their inventory, according to the company’s March letter to healthcare providers. The letter was provided to MedTech Dive by ECRI, a nonprofit focused on patient safety.
In the letter, Boston Scientific said it had received no reports of patient harm related to the problem. However, the company wrote that serious adverse health consequences including stroke or myocardial infarction due to embolization of detached material are possible, though unlikely.
Boston Scientific added that all issues reported to date occurred while the device was outside the patient’s body.