The Food and Drug Administration is warning doctors — and the public — about an growing but largely unrecognized problem plaguing surgery patients: UFDs.

Unretrieved device fragments, medical devices that break and leave behind potentially deadly debris after surgery, is responsible for at least 72 deaths and 4,675 injuries since 2003, an FDA database reports.

This is on par with mistakes that have received far more attention — sponges and instruments left in abdominal cavities — with this difference: doctors usually know they’re there, but they either make no attempt to retrieve the devices or are unsuccessful when they try.

FDA records show that more than 200 medical devices contribute to the problem. The most common problem occurs when wire guides for catheters used in heart operations break or fracture, leaving the device or fragments behind. Bone screws used in orthopedic operations are often culprits as well.

Some health workers don’t tell their patients about the broken devices, sending them home with pieces that have the potential to migrate throughout the body, or to interact with future procedures such as magnetic resonance imaging.  One worry is that metal objects can overheat during MRIs, scorching patients from the inside.

While the FDA works to develop some sort of reporting system, it’s up to patients to protect themselves. Ask doctors to explain potential complications of medical procedures and devices well before surgery begins. If a device is being removed, they should ask to see it. Afterward, they should ask if anything was left behind.

If you are suffering from this sort of problem, seek out an experienced lawyer who can help you with professional insight and to determine what sort of financial compensation is available.

Back in February, the United States Supreme Court dealt a hefty blow to citizen protection to seek compensation after being injured by a defective medical device. In this landmark case, our highest court ruled against Charles Riegel, the victim of a defective balloon catheter used during his angioplasty procedure. Though Riegel was seriously injured at the negligent hands of Medtronic, the court found that Federal regulations overruled state law, rather than the two working in tandem as it had been before.

The repercussions of this decision have yet to take their full effect. As Public Citizen lawyer Allison Zieve noted, “The possibility of being held liable for injuries their products cause creates an invaluable incentive for manufacturers to make their products as safe as they can, to revise labels… and to remove unsafe products from the market.”

Luckily, the consumer advocacy group Public Citizen is working to remedy this gaping hole in consumer protection. With the support of Representatives Henry Waxman and Frank Palone, and Senators Ted Kennedy and Patrick Leahy, they are trying to push through the Medical Device Safety Act of 2008. This new legislation would nullify the implications of the Supreme Court ruling, and give power back to the injured.

The FDA announced a Class I recall of Cordis balloon catheters on January 18, 2008 due to the risk that the balloon may either slowly deflate, or not deflate at all after insertion for angioplasty.

If the angioplasty balloon does not properly deflate, it may result in a total blockage of the artery. A blocked artery may cause:

• A change in heart rate
• A change in heart rhythm
• Injury to the artery
• Heart attack

A faulty angioplasty balloon may require surgery, or result in death. The lots affected by the recall are all Dura Star™ and Fire Star™ 13173912 through 13315455. In addition, 52 lots above 13315455 are affected. No lots above 13329055 are affected. The Cordis balloon catheters are used during angioplasty, when a balloon is inserted in order to open a narrowed or blocked artery in the heart.

The Cordis balloon catheters were recalled by the FDA as a Class I. A Class I recall is the most serious type of recall, as it pertains to situations where there is a probability that the product may cause serious injury or death.

If you or a loved one has sustained serious or fatal injuries due to Cordis Dura Star™ RX, Fire Star™ RX PTCA balloon catheters, contact a Cordis balloon catheter attorney at Cappolino Dodd Krebs LLP at 1-800-460-0606. An experienced Cordis balloon catheter lawyer will be able to evaluate if you are eligible to seek compensation.