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| Expel Drainage Catheter--Courtesy of Boston scientific |
Boston Scientific ($BSX) is initiating a recall of some of its biliary drainage catheters after 11 reports of device fragmentation, according to the FDA's recall database. The recall is labeled Class II, meaning the device "may cause temporary or medically reversible adverse health consequences."
The FDA says the most serious foreseeable risk posed by the faulty versions of the Expel Drainage Catheter and Kit is reintervention to remove the fragment. A total of 289 units were recalled in four U.S. states and various European countries.
Boston Scientific sent a recall letter in February to affected customers, describing the action needed to be taken by the customer. The recall is ongoing, according to the FDA. The agency's recall notice contains the affected lot numbers.
The Expel is intended for internal and external percutaneous (or needle puncture-based) drainage of the biliary system. It contains a drainage hole on its distal end. The biliary system consists of the stomach, liver and duodenum, the top-most part of the small intestine. It secretes bile, used to digest food and carry waste from the liver to the small intestine.
The device was FDA-cleared in October.
On its website, Boston Scientific says the Expel is better than competitors from Bard, Cook Medical, and AngioDynamics due to good flexibility, buckling resistance strength resistance.
- read the recall notice
- here's the 510(k) document indicating FDA clearance