Medical Devices
FDA Preliminary Public Health Notification*: Possible Contamination and Malfunction of Heart Valves and Valve Conduits, Annuloplasty Rings, Surgical Grafts, Meshes and Other Devices Manufactured by Shelhigh, Inc.
(You are encouraged to copy and distribute this notification.)
Issued: May 18, 2007
Previous Publication: April 18, 2007
Dear Healthcare Practitioner:
This is to notify you that all medical devices manufactured by Shelhigh, Inc. of Union, N.J. were manufactured under conditions that may have contaminated the devices and may result in devices that fail to function for the expected life of the products. We are also recommending actions that could help minimize risks to patients.
Background
FDA’s inspections of Shelhigh, Inc. revealed significant manufacturing problems that included improper sterilization and extension of expiration dates for the firm’s medical devices. The U.S. Marshals have seized at FDA’s request all the medical devices at the Union, N.J. manufacturing plant. The FDA has also issued a formal written request to Shelhigh, Inc. to recall all of its medical devices remaining in the marketplace, including hospital inventories.
To identify a device manufactured by Shelhigh, Inc., we recommend that you first check for the company’s name and address, which we believe are consistently displayed on the device packaging. Below are some brand names known by FDA of medical devices manufactured by Shelhigh, Inc., including those made for another company and those that have not been cleared/approved by FDA:
| Brand Name | Company’s Name and Address |
|---|---|
| Shelhigh, Inc. 650 Liberty Avenue , Union New Jersey 07083 or 67-71 East Willow Street Milburn, NJ 07041 |
| Integra NeuroSciences or Integra LifeSciences Corp. 311 Enterprise Drive Plainsboro, NJ 08536 |
Recommendations
1. Consider using alternative devices.
2. We recommend that you assess the overall health status of each patient implanted with a Shelhigh, Inc. device, and provide the testing, monitoring and care that is appropriate considering each patient’s individual case. The following information will help with your assessment:
- Shelhigh, Inc. received FDA’s clearance to market medical devices beginning in 1997.
- We are aware of published reports of premature (accelerated) failure associated with some Shelhigh devices.
- A Shelhigh device could potentially be contaminated with bacteria, fungi, or endotoxin.
3. You may wish to provide to your patients the FDA’s Preliminary Advice For Patients.
4. If you note a failure or problem with a Shelhigh device, please follow the reporting instructions below.
Reporting Adverse Events to FDA
Hospitals and other user facilities have an obligation under 21 CFR Part 803, to report certain device-associated death and serious injury events to FDA and/or the device manufacturer. Typically, device-associated deaths are to be reported to the manufacturer and FDA; device-associated serious injuries are to be reported to the manufacturer or to FDA if the manufacturer is unknown. We are asking you to please consider sending a copy of all reportable device-associated events to both FDA and Shelhigh, Inc.
If you suspect that a death or serious injury may have been associated with the use of a device manufactured by Shelhigh, Inc., please immediately notify the Medical Device Reporting (MDR) contact person at your facility. If a Shelhigh device was explanted because of actual or suspected infection please include details of any analysis you may have conducted. Also, let your MDR contact person know that FDA is requesting a copy of the event report. The event should be reported to FDA on the Form 3500 A.
User facilities do not have a mandatory obligation to submit malfunction events to either FDA or the device manufacturer. However, in this situation we are asking that you report such events to FDA through our MedWatch Adverse Event Reporting program, especially if you have evidence or suspicion of a malfunction involving Shelhigh devices.
You can report events to FDA in a number of ways. Access to FDA report forms 3500 and 3500A, and information on completing these forms, are available at the MedWatch internet site. Mandatory reports go on Form 3500A; completed forms must be mailed (cannot be submitted online) to FDA at 5600 Fishers Lane, Rockville, MD 20852-9787. Voluntary reports using Form 3500 can be submitted any of the following ways: (1) online from the MedWatch site, (2) entered on a downloaded form and mailed to FDA or faxed to 1-800-FDA-0178, or (3) reported by telephone to 1-800-FDA-1088.
Getting More Information
FDA Medical Device Public Health Notifications are available on the Internet. You can also be notified through email each time a new Public Health Notification is added to our web page. To subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39.
Sincerely yours,
Daniel G. Schultz, MD
Director
Center for Devices and Radiological Health
Food and Drug Administration
*CDRH Preliminary Public Health Notifications are intended to quickly share device-related safety information with healthcare providers when the available information and our understanding of an issue are still evolving. We will revise them as new information merits and so encourage you to check this site for updates.
If you have questions about this Notification, please contact FDA's Division of of Small Manufacturers, International and Consumer Assistance (DSMICA) by e-mail at dsmica@fda.hhs.gov or by phone at 1-800-638-2041 or 301-796-7100
