Embolism risk prompts FDA to treat Boston Scientific recall as Class I event

Dive Brief:

FDA has categorized Boston Scientific's Feb. 11 recall of Imager II 5F Angiographic Catheters as a Class I event, reflecting the potential for the devices to cause serious injuries or death.
In a recall alert published Tuesday, FDA flagged the potential for the catheter tip to detach during a procedure. The agency has received reports of nine injuries related to the problem.
FDA's alert comes weeks after Boston Scientific issued a field safety notice warning users of the devices of the potential for detached tips to cause life-threatening blood flow obstructions, or embolisms.

Dive Insight:

Healthcare professionals use the Boston Scientific devices in the delivery of contrast agents to carotid arteries and other blood vessels. The process is facilitated by a tip that Boston Scientific designed to be soft enough to reduce the risk of trauma.

But in raising the issue to healthcare professionals, Boston Scientific said it had "noted an increase in the rate of tip detachment complaints" related to certain lots of its catheters. Boston Scientific told users the most common injury linked to the issue stems from the detachment of the tip inside of the patient.

At best, the detachment of the tip would require additional surgical intervention. However, if the fragment remained in the patient it could cause a prolonged hospitalization, embolism, stroke or death.

In light of the threat, Boston Scientific is recalling 12 lots of the catheters that may be affected by the problem. The recall covers 6,130 devices distributed in the U.S.

Boston Scientific advised customers in a Feb. 11 letter to remove affected devices from inventory, stop using them and return them to the company.

Publicly, there is some uncertainty about why the tips of those devices are more likely to detach. At the time of its field safety notice, Boston Scientific said its preliminary investigation had found the affected lots met design and manufacturing standards. The problem seemed to stem from "external factors" that "may have contributed to the tips of devices in these batches becoming brittle, leading to the tip detaching."

The recall is the first involving the Imager II catheter since 2017, according to FDA's medical device recalls database, and appears to be the first-ever Class I event. Most of the earlier recalls of the angiographic catheters stemmed from packaging errors and faults.