Shelhigh Medical Devices Recalled
Orlando, Florida
Shelhigh, Inc. makes a wide variety of medical devices for use in infants, children, and adults. Any and all devices made by Shelhigh are currently suspect for contamination with bacteria, fungi, and endotoxin, which can lead to infection, premature device failure, serious injury, and even death.
After warnings and meetings with Shelhigh regarding deficiencies in their manufacturing process, primarily insufficient sterilization, on April 17, 2007, U.S. Food and Drug Administration (FDA) investigators and U.S. Marshals seized all implantable medical devices from Shelhigh's manufacturing facility in Union, N.J.
Shelhigh devices are used in many types of surgery including brain, heart, lung, spine, abdominal, pelvic, and shoulder surgery for repair of soft tissue injuries and heart valve replacement surgery. They are used in people of all ages, from babies to the elderly.
Devices which may be contaminated include:
- Shelhigh Pericardial Patch
- Shelhigh No-React Pericardial Patch
- Shelhigh No-React PneumoPledgets
- Shelhigh No-React VascuPatch
- Shelhigh No-React Tissue Repair Patch/UroPatch
- Shelhigh Pulmonic Valve Conduit No-React Treated
- Shelhigh No-React Dura Shield
- Shelhigh BioRing (annuloplasty ring)
- Shelhigh No-React EnCuff Patch
- Shelhigh No-React Stentless Valve Conduit
- Shelhigh Internal Mammary Artery
- Shelhigh Gold perforated patches
- Shelhigh Pre Curved Aortic Patch (Open)
- Shelhigh NR2000 SemiStented aortic tricuspid valve
- Shelhigh BioConduit stentless valve
- Shelhigh NR900A tricuspid valve
- Shelhigh MitroFast Mitral Valve Repair System
- Shelhigh BioMitral tricuspid valve
- Shelhigh Injectable Pulmonic Valve System
The FDA recommends that doctors consider using alternative devices and monitor patients who already have Shelhigh devices for infections and possible device failure, indefinitely, because problems could develop at any time, not just immediately after implantation. The FDA also says that removal may not be necessary. The potentially contaminated devices have been available for about ten years.
For those who have, or think they may have, one of these devices, the FDA recommends:
- If you don't know if you have one of the devices in question, contact the doctor who performed your surgery.
- If you know you have one of the devices in question, you should:
- Contact your doctor promptly
- Follow your doctor's instructions on care after surgery
- Do not miss any follow-up appointments with your physician
- Contact your physician if you have ANY signs of infection, such as
- Fever
- Unusual pain, swelling, redness, and warmth in the area of your implant
- Drainage or discharge from the incision used during the procedure to implant the device
- Inform all your doctors about your surgery and that you may have a Shelhigh device implanted.
Contact the defective medical device attorneys at Colling Gilbert Wright & Carter today if you or a loved one has become ill or died due to the use of a Shelhigh device, or if you believe that you or a loved one may be affected by the recall, in Orlando or anywhere in Florida. We will evaluate your claim for free and we will represent you on a contingent fee basis, which means you won't have to pay any attorneys' fees unless you recover on your claim.
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