U.S. regulators are requiring Baxter Healthcare Corp. (NYSE:BAX) to pull all of its Colleague infusion pumps from the market, accusing the medical device manufacturer of a “long-standing” failure to correct problems with the pumps.
As part of its enforcement action, the Food & Drug Administration ordered the Deerfield, Ill.-based company to provide refunds to customers or to replace the pumps at no cost. Both the agency and the company estimate there are about 200,000 of the pumps currently in use.
Baxter officials said the recall could cost the firm between $400 million to $600 million, recorded as a special pre-tax charge against its first-quarter financial results, according to a press release. They also said the company will soon propose alternative remedies to the recall notice issued late last week by the FDA and publicly disclosed late May 3.
The agency and Baxter have sparred since 1999 over alleged design flaws with the pumps, which are designed to deliver medications and other fluids into patients at a controlled pace. Under the terms of a June 2006 consent degree, the FDA can order a recall or demand other remedial actions to bring the pumps into compliance.
In a statement issued late May 3, the FDA acknowledged several changes Baxter made to the pumps in recent years, but also said the company failed to correct an underlying product defect, prompting the current recall. Among the problems the agency cited were battery swelling, power to the pumps inadvertently switching off, service data errors and other issues.
According to the federal watchdog agency, Baxter submitted a proposed correction schedule April 8 stating it did not plan to begin a new round of corrections until May 2012 and would not complete the repairs until the following year.
After issuing nearly 20 recalls over the past five years, the FDA has been moving toward stricter regulation of infusion pumps, proposing new guidelines for manufacturers last month that likely will require more stringent clinical trials before the agency clears the devices.
Overall, the FDA said it received more than 56,000 complaints associated with the use of infusion pumps, scores of which resulted in serious injuries and 500 deaths.