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Boston Scientific Infusion Ports

Boston Scientific Infusion Ports Side Effects Lawsuits | Side Effects: Surgery, Personal Injury, Device Removal Surgery | Defective Valves, Undesired Part Separation, Drug Leakage

Boston Scientific Infusion Ports Side Effects Could Lead To Removal Surgery Lawsuits

Boston Scientific Infusion Ports | Lawsuits, Lawyers | Side Effects: Surgery, Personal Injury, Device Removal Surgery | Defective Valves, Undesired Part Separation, Drug Leakage

Hundreds of patients may need surgery to remove an implanted drug-injection device, the Vaxcel Low Profile Infusion Ports made by Boston Scientific Corp., the company said yesterday after federal regulators cited it for quality-control problems. A spokesman for Boston Scientific said it has been advising doctors to consider surgery if their patients have one of the 1,000 drug-infusion ports it recalled in March. In addition, the company said it will recall another 1,000 ports this week, in response to a warning letter it received May 18 from the Food and Drug Administration about quality-control standards.

The letter, which was posted yesterday on the FDA's website, said Boston Scientific failed to establish manufacturing controls for the quality of the devices and did not properly track quality concerns. The problems could cause the ports to leak drugs into unintended parts of the body, though the company said it knew of only one possible report of a patient injury. The FDA's letter directed the company to fix problems it called ''serious violations of the law" that could result in fines, product seizures, or other penalties.

Infusion ports make it easier to treat cancer patients and others who need frequent drug injections by avoiding repeated needle-sticks directly into a blood vessel. Typically, the ports feature a circular surface made of silicon-like material about the size of a 50-cent piece that is implanted under the skin, often just below the clavicle. Needles poked through the port's surface deliver drugs that flow through a catheter surgically attached to a vein. According to the FDA's letter, Boston Scientific started reviewing its manufacturing procedures Aug. 26 after receiving a complaint that the two plastic pieces that form the port's cover and base had separated, possibly because they weren't correctly welded.

It received at least four more complaints through Feb. 9, and on March 9 launched a voluntary recall of all 1,000 ports it had shipped to date that included valves to stop blood from flowing up from the catheter to the reservoir. At the time, Boston Scientific said it didn't need to recall ports made without valves because the company hadn't received complaints about those models. But the FDA's letter said it did receive a complaint Jan. 5 about a ''leak in the membrane" of a non-valved port.

The company was warned for failing to maintain adequate procedures to identify actions 'to correct and prevent the recurrence of nonconforming product and other quality problems. This technology became widely used by the 1990s.

Legal Help For Victims Affected By Boston Scientific Infusion Ports

If you or a loved one suffered injuries from a Boston Scientific Infusion port, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).



 

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Recall for Boston Scientific Implantable Defibrillators

Mar 16, 2010 | Parker Waichman LLP
A massive recall is being issued for seven brands of Boston Scientific implantable heart defibrillators.  The recall is being issued because Boston Scientific has determined that it did not get approval from federal regulators for changes to its manufacturing processes. According to a Boston Scientific press release, the company is halting sales and retrieving field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators...

Lawsuits Allege Medtronic, Other Firms Illegally Marketed Surgical Ablation Products

Jul 16, 2009 | Parker Waichman LLP
Medtronic Inc., St. Jude Medical Inc., AtriCure Inc. and Boston Scientific Corp. all allegedly paid kickbacks to doctors in order to convince them to use their surgical ablation products to treat the heart-rhythm defect called atrial fibrillation, according to lawsuits recently unsealed in Texas.   According to The Wall Street Journal, the lawsuits were filed by former employees of the companies.Allegations of kickbacks by medical device makers are nothing new.  For example, in...

Boston Scientific Shares Dip on Letter News

Aug 23, 2005 | AP
Federal regulators sent Boston Scientific Corp. a warning letter identifying "serious regulatory problems" in medical devices shipped from a Quincy, Mass., distribution plant, including heart stents sent to hospitals despite a quality control problem. The U.S.Food and Drug Administration's disclosure of the letter on Tuesday sent shares of Boston Scientific down nearly 5 percent in morning trading to a new 52-week low. A letter to the company dated Aug. 10 said FDA inspectors found "serious...

Boston Scientific Recalls Device After FDA Warning

Jun 1, 2005 | Boston Globe
Hundreds of patients may need surgery to remove an implanted drug-injection device made by Boston Scientific Corp., the company said yesterday after federal regulators cited it for quality-control problems.A spokesman for the Natick medical-devices giant said it has been advising doctors to consider surgery if their patients have one of the 1,000 drug-infusion ports it recalled in March. In addition, the company said it will recall another 1,000 ports this week, in response to a warning letter...

Boston Scientific to Recall Infusion Ports

Jun 1, 2005 | UPI
Boston Scientific Corp. said it will recall another 1,000 drug infusion ports in response to a stern warning from the U.S. Food and Drug Administration. The FDA warning, issued May 18 and posted this week on its Web site, said Boston Scientific failed to establish quality controls for making the infusion ports and failed to properly track quality concerns, including leaking, that the FDA called "serious violations of the law."Hundreds of patients may need surgery to remove the device, the...

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