Boston Scientific recalls Fetch 2 thrombectomy catheters

Boston Scientific (NYSE:BSX) recalled the Fetch 2 aspiration catheter it acquired from Bayer (ETR:BAYN) in 2014, after receiving complaints of shaft breakage during coronary thrombectomy procedures.

There were no injuries or deaths reported from the shaft breakage and there is no risk to patients who have already had thrombectomies using the Fetch 2 device, Marlborough, Mass.-based Boston Scientific said. The Class I recall, the FDA’s designation for problems that could cause serious injury or death, affects all 21,155 of the Fetch 2 catheters the company has on the market.

Boston Scientific closed the $415 million cash buyout Bayer’s interventional unit in September 2014. The deal added atherectomy and thrombectomy devices including the Fetch 2, the AngioJet thrombectomy system and the JetStream atherectomy device to the BSX portfolio. the recalled devices still bear the Bayer label, Boston Scientific said April 8.

The shaft breakage incidents that prompted the March 22 recall were all resolved without further complications, by either removing the broken section while it was still partially attached to the catheter shaft or by using a snare on detached particles, the company said. The main risk related to the March 22 recall is embolism of device fragments, “which could lead to obstruction of blood flow or additional intervention to remove a device fragment surgically,” Boston Scientific said.

Healthcare providers should immediately stop using all Fetch 2 devices and return any unused products to Boston Scientific, the company said. The affected devices were made between June 11, 2014, and February 19 and carry the following universal product numbers:

Fetch 2 Catheter UPNs

FETCH2 US 109400-001

FETCH2 OUS 109400-002

FETCH2 Canada 109400-003

FETCH2 Japan 109400-004

FETCH2 EU 109400-005

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