FDA: Abbott Issues Voluntary Recall of Coronary Catheters

Abbott Vascular has initiated a voluntary coronary catheter recall for specific lots of three catheters manufactured and distributed between 2015 and 2017. According to the U.S. Food and Drug Administration (FDA), the recalled catheters may exhibit difficulty in removing the protective balloon sheath, which could cause problems with inflating or deflating the balloon. Affected patients and their families may be eligible to seek compensation with the help of a defective medical device lawyer.

For more information, contact Attorney Group today. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated coronary catheter recall lawyer who can assist you throughout the legal process.

The time you have to pursue a claim is limited. Contact us for more information.Get Help Now.

Abbott Vascular, a subsidiary of health care company Abbott Laboratories, has initiated a voluntary recall of specific lots of the following catheters:

  • NC Trek RX Coronary Dilatation Catheter
  • NC Traveler Coronary Dilatation Catheter
  • CC Tenku RX PTCA Balloon Catheter

According to the FDA, the protective balloon sheath in recalled products may be difficult to remove, which could lead to problems associated with inflating or deflating the balloon. Potential risks include air embolism, additional intervention, thrombosis and myocardial infarction. One reported case resulted in multiple post-surgical complications eventually leading to the death of a patient after the balloon failed to deflate. For a complete list of affected lots, please see Abbott’s field safety notice.

The total number of potentially affected products is approximately 449,661. Affected catheters were manufactured between January 1, 2015 and January 2, 2017, and were distributed between January 13, 2015 and March 14, 2017. Abbott began contacting customers in March who received coronary catheters from the affected lots and is arranging the return and replacement of all remaining products. However, the recall does not affect patients who have successfully undergone cardiac procedures using these devices. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of Abbott coronary catheters to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

How an Abbott Coronary Catheter Recall Lawyer Can Help 

Medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.

People injured by a defective coronary catheter may be eligible to recover money for:

  • Medical Expenses
  • Lost Wages
  • Pain and Suffering

The families of those killed may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.

The Time You Have to Pursue a Claim is Limited. Contact Us Today.

For more information, contact Attorney Group. You can fill out the form on this page or contact us by phone or email.

After you contact us, an attorney will follow up to answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.

Please note that the law limits the time you have to pursue a claim or file a lawsuit for an injury. If you think you have a case, you should not delay taking action.