Medtronic Cardiac Guidewire Device Recall
On November 15, 2013 the FDA classified several models of Medtronic, Inc.’s cardiac guidewire products as a Class I Recall. In October, Medtronic had initiated a voluntary internal investigation of its guidewires after receiving complaints regarding the product. They took initiative and informed hospitals from around the world that the coating on the surface of the guidewire may potentially detach and cause injury to patients. They also asked that the guidewire be returned to Medtronic for credit and replacement. Thereafter, the FDA has reviewed Medtronic’s investigation and decided to classify the cardiac guidewire products as a Class I recall.
What Is a Class I Recall?
A Class I recall is the most serious and alarming of FDA recalls. Class I recalls are used to recall dangerous products that are reasonably certain to cause serious health problems or even death. In this case, the FDA believes that the recalled guidewires have the potential to cause injury or death to patients.
What Are Medtronic Guidewires?
According to the FDA, Medtronic’s guidewires are used for the following:
- To assist percutaneous coronary interventions
- For the “placement of left ventricular leads for cardiac rhythm devices”
Recalled Medtronic Product Information
- Recalling Firm: Medtronic, Inc.
- Reason For Recall: Coating on the surface of the guidewires may detach
- Which kits are the DBS lead caps included in? The DBS lead cap is included in DBS lead kits and dystonia therapy kits
- What are DBS lead caps used for? DBS lead caps are sometimes used to protect the end of a DBS lead after it has been implanted.
Click for more information about the Medtronic Guidewire Class I recall.
Additional Medtronic Recall Information:
If you have experienced or observed any consequences associated with guidewire coating issues, you should report the it to Medtronic at 1-877-526-7890.
Adverse reactions or quality problems may be reported to FDA MedWatch. You may report the problem to MedWatch by either mailing in the reporting form, faxing the form, or by calling at 1-800-FDA-1088.
What to Do if a Recalled Product Has Affected You:
If you or a loved one has suffered injuries as a result of a recalled product, you may be entitled to compensation. It would be beneficial to speak to an attorney specializing in products liability. Most of the attorneys here at LawInfo.com offer free initial consultations. It would be advantageous to at least discuss your case with an attorney to get some feedback.
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