Boston Scientific Halts Imager II Catheter Sales After Two Serious Injuries, Adding To A Difficult Year

Boston Scientific has told customers to stop using its Imager II angiographic catheters and remove them from where they are used or sold after finding a manufacturing issue affecting the device tips. In an FDA early alert, the regulator said Boston Scientific sent the customer letter on August 24.

According to the company, the catheters were made with "reduced levels of stabilizing agents in the tips," a problem that could increase the risk of tip degradation and detachment. The FDA said the most serious risk is a life threatening embolism caused by a device fragment obstructing blood flow and resulting in end organ failure.

The device issue

Imager II angiographic catheters are used to capture images of the body’s blood vessels. The current action is a sales and use halt rather than a narrower warning about technique or patient selection, which points to a product-level manufacturing concern.

Boston Scientific had reported two serious injuries and no deaths associated with the issue as of July 16, according to the FDA. The alert said there have been no subsequent updates.

The commercial picture

The halt lands in an already difficult stretch for Boston Scientific. Less than a week earlier, the company disclosed a serious cyberattack that affected its global operations and aspects of its manufacturing base. Earlier this year, it also announced a restructuring plan that could lead to "some headcount reductions" and lowered its top guidance estimates by 2% amid sales headwinds.

The latest alert also revives an older concern around catheter tip integrity. Two years ago, Boston Scientific was the subject of a Class I recall from the FDA after reports that the tip broke off one of its devices while inside a patient. Even without reported deaths in the current case, repeat tip-related problems can carry more weight with hospitals and regulators because they speak to reliability as much as to isolated event counts.