The Food and Drug Administration (FDA) is warning all cardiovascular, neurosurgical and other surgical healthcare professionals, hospital risk managers and consumers that all medical devices manufactured by Shelhigh, Inc. were manufactured under contaminated conditions.
This may cause the device to fail and properly function causing serious infection leading to serious injury or death. The FDA has currently seized all implantable medical devices made by Shelhigh, Inc. and is recommending actions to help minimize risks to patients.
Serious Manufacturing Problems
An inspection at Shelhigh, Inc. in Union, NJ revealed serious manufacturing concerns to the FDA. On April 17, 2007, the US Marshals office seized all implantable medical devices due to improper sterilization techniques used by Shelhigh, Inc., as well as extension of expiration dates for their medical devices.
Shelhigh, Inc. Brand Medical Devices:
- Endura No-React Dural Substitute
- Shelhigh BioRing™ (annuloplasty ring)
- Shelhigh Gold™ perforated patches
- Shelhigh Internal Mammary Artery
- Shelhigh No-React® Dura Shield
- Shelhigh No-React® EnCuff Patch
- Shelhigh No-React® Pericardial Patch
- Shelhigh No-React® PneumoPledgets
- Shelhigh No-React® VascuPatch
- Shelhigh No-React® Stentless Valve Conduit
- Shelhigh No-React® Tissue Repair Patch/UroPatch™
- Shelhigh Pericardial Patch
- Shelhigh Pre Curved Aortic Patch (Open)
- Shelhigh Pulmonic Valve Conduit No-React® Treated
- Shelhigh BioConduit™ stentless valve
- Shelhigh BioMitral™ tricuspid valve
- Shelhigh Injectable Pulmonic Valve System
- Shelhigh MitroFast® Mitral Valve Repair System
- Shelhigh NR2000 SemiStented™ aortic tricuspid valve
- Shelhigh NR900A tricuspid valve
These products are "pediatric heart valves and conduits (tube-like devices for blood flow), surgical patches, dural patches (to aid in tissue recovery after neurosurgery), annuloplasty rings (to help repair heart valves) and arterial grafts. The tissue-based devices are used in many surgical settings, including open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery"
(FDA Initial Press Release).
If you or a loved one was implanted with a Shelhigh implant, contact the
Law Offices of Handler Henning & Rosenberg, LLP at 1-800-461-4140 to discuss your case.
FDA Recommendations -
It is important to access the overall health status of each case and it is recommended to try using alternative devices for your medical needs. The FDA has preliminary advice for patients. If you do notice any malfunctions or suspect that a death or serious injury was associated with your Shelhigh medical device, report it to the FDA.
Contact Handler Henning & Rosenberg, LLP at 1-800-461-4140 for a FREE Consultation and more information regarding Shelhigh, Inc. medical devices.
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