Category: Pumps

FDA forces Baxter infusion pumps off the market

May 4, 2010 by MassDevice staff

Citing "long-standing" problems, the Food & Drug Administration orders Baxter Healthcare to take its Colleague infusion pumps off the market in a move that could cost the firm up to $600 million.

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.

UPDATE: Fluidnet's CEO on its $9 million funding round

March 11, 2010 by MassDevice staff

Portsmouth, N.H.-based IV infusion system developer Fluidnet Corp. drums up $9 million in an equity sale that CEO Jeff Carlisle says will go toward end-stage development and getting the product to market this year.

Fluidnet Corp. CEO Jeff Carlisle fairly bristles when he reads his company described as an IV infusion pump maker, as MassDevice did in the first version of this story published March 11.

His company's system is so advanced compared with current infusion systems, he says, calling it a pump is just not accurate.

"To characterize this as an infusion pump company would be so misleading. We're really taking a holistic look at the IV therapy process," Carlisle told MassDevice. "The information flow is an important as the fluid flow."

HeartWare, Thoratec spike $282 million merger deal

July 31, 2009 by MassDevice staff

Heart pump makers kill their proposed $282 million merger after the FTC moves to block it on anti-trust grounds, avoiding a lengthy (and costly) legal battle.

HeartWare International Inc. and Thoratec Corp. agreed to spike their proposed, $282 million merger in the face of opposition from the U.S. Federal Trade Commission.

HeartWare CEO upbeat despite FTC move to block Thoratec buyout

July 31, 2009 by MassDevice staff

HeartWare International Inc. president and CEO Doug Godshall was upbeat in a letter to shareholders accompanying a securities filing, writing that the company is on sound footing despite a move by the U.S. Federal Trade Commission to block its proposed acquisition by Thoratec Corp.

FTC moves to block Thoratec's buyout of HeartWare

July 30, 2009 by MassDevice staff

The U.S. Federal Trade Commission plans to file a lawsuit to spike the cardiovascular device makers' proposed $282 million merger on anti-trust grounds.

The U.S. Federal Trade Commission plans to file a lawsuit seeking to block the proposed $282 million merger of Thoratec Corp. and HeartWare International Inc.

Saying it believes the merger "would substantially reduce competition in the U.S. market for left ventricular devices," the commission alleged that Thoratec already enjoys a monopoly on the sale of LVADs in the U.S. and would only increase its hegemony if the merger is consummated.

Idex consolidates its Massachusetts footprint

March 27, 2009 by MassDevice staff

Illinois-based medical device components giant consolidates two facilities into a single, 80,000-square-foot plant in Middleborough.

Idex Corp. is consolidating its footprint in the Bay State into a single plant in Middleborough.

The massive, Illinois-based medical device component parts maker broke ground on an 80,000-square-foot manufacturing plant in Middleborough's Campanelli Business Park for its Idex Health & Science division.

That segment, which accounts for more than 20 percent of its parent company's total sales, pulled in about $331 million in sales last year.