Durata Lead Problems Prompt FDA Warning Letter
Last Updated on January 11, 2022
Important Information
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At A Glance
- This Alert Affects
- Patients who have been implanted with a defibrillator containing a lead, or electrical wire, known as Durata. This product is manufactured by St. Jude medical.
- Damages
- Patients who were injured by the Durata defibrillator lead may be entitled to compensation for medical bills and other damages.
- Company(ies)
- St. Jude Medical
- Additional Details
- The Durata lead is an electical wire which connects a defibrillator to the patient's heart.
- Date
- In Oct. 2012, the FDA conducted an inspection of a St. Jude manufacturing plant in California, finding 11 problems related to the design and manufacture of the Durata defibrillator lead.
Patients who were injured due to problems with a Durata defibrillator lead may have legal recourse. It has been reported that the product’s manufacturer, St. Jude Medical, failed to address concerns uncovered during an inspection at one of the company’s facilities in California. The FDA inspection report revealed 11 problems related to the design and manufacture of the Durata leads; however, the manufacturer failed to adequately correct nearly half of these issues, prompting a strongly-worded letter from the FDA threatening fines, injunctions and other actions against the company.
Injured by a Durata defibrillator lead? You may be able to file a lawsuit against St. Jude to recover compensation for medical bills and other damages.
Durata Failures Similar to Recalled Riata Leads?
The recent warning from the FDA was issued amidst growing concerns that failures of the Durata leads are similar to those seen in another troublesome lead manufactured by St. Jude. In 2011, the company’s Riata leads were recalled after it was discovered that insulation problems could cause the defibrillator to send unnecessary shocks to the heart or fail to deliver life-saving therapy. A study published several months after the Class I recall found that 22 deaths were linked to insulations failures in the Riata leads. A follow-up study also found at least one death linked to failures of the Durata lead.
Inspection Uncovers Durata Lead Problems
When inspecting St. Jude’s manufacturing facilities in Sylmar, California, the FDA found 11 different violations related to the design and manufacture of the Durata leads. These violations included failure to establish and maintain proper procedures for verifying the component’s design and failure to establish and maintain plans for implementing corrective and preventative action. When St. Jude failed to adequately correct these violations, the FDA sent the company a warning letter which also stated that the Durata leads were “misbranded” because the medical device maker failed to report malfunctions of the lead which may have caused death or serious injuries.
Injured by a St. Jude Durata Lead?
If you or a loved one has been injured by a St. Jude Durata defibrillator lead, you may be able to file a claim seeking compensation for medical bills and other damages. To have your claim evaluated, at no cost to you, complete the form on the right with information on your Durata lead problems.
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