Shelhigh Devices
On April 17, 2007, FDA investigators and US marshals seized all implantable devices from Shelhigh, Inc. after reports of deficient manufacturing processes. The seizure follows an FDA investigation and multiple warnings regarding the safety and effectiveness of Shelhighs’ medical products. The devices manufacturer has been asked several times by the FDA to conduct a voluntary recall of the devices in question but declined to do so.
Shelhigh was cited with failing to adhere to the Quality System Regulations required by law. Additional health and safety violations include:
- Manufacturing products in a facility with a poorly constructed and poorly maintained clean room where sterilized devices are processed
- Failing to adequately monitor critical manufacturing environments for possible contamination
- Failing to support product expiration dates
- Manipulating product expiration dates.
Medical devices manufactured by Shelhigh:
- 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.
Shelhigh medical devices are most commonly used for heart valve replacement and to repair internal soft tissue structures. The manufacturer also offers a wide variety of cardiothoracic surgical solutions including valves and conduits (tube-like medical devices used for increasing blood flow and circulation), surgical patches, arterial grafts, dural patches and annuloplasty rings. All of these products are currently under investigation by the FDA for possible contamination.
If you or a loved one have experienced any major side effects as a result of a contaminated Shelhigh Medical Device, please call us at 1.800.966.4999 or fill out our online contact form for a free case evaluation.
