FDA Issues Class I Recall of Latex Balloon Catheters

class I recall, balloon catheters

The U.S. Food and Drug Administration (FDA) has designated a recall of Applied Medical latex balloon catheters as a Class I recall.  This is the most serious medical device recall designation, meaning that there is a,

“Reasonable probability that using the product will result in serious adverse health consequences or death.”

Class I Recall of Latex Balloon Catheters

According to the FDA’s recall announcement, Applied Medical initially recalled the latex balloon catheters in October 2019.  These catheters are used to clear temporary blockages, infusion of fluids and closing off blood vessels.  The reason for the recall is because the catheter tip may detach during use.  This could result in small pieces of the catheter breaking off inside the patient.

This medical device malfunction could cause serious harm to patients, including:

  • Damage to blood vessels
  • Additional surgery required to remove pieces of the device
  • Death

Since 2015, there have been at least 45 complaints about the tip detaching.  The FDA has also received three reports.  Each of these three reports involves one of the catheters subject to this Class I recall.  That includes the following models:

  • Python Embolectomy Catheters – A4E01, A4E02, A4E03, A4E04, A4E05, A4E06, A4E08, A4E09.
  • Bard Embolectomy Catheters – CE0340DR, CE0380DR , CE0440DR,CE0480DR CE0540DR, CE0580DR, CE0680DR.
  • OTW Latis Cleaning Catheter – A4GW6

The recalled catheters were manufactured between July 2015 and November 2018.  They were distributed between August 2015 and March 2019.  The FDA estimates 19,400 devices are subject to this Class I recall.

What to Do about The Catheters Subject to Class I Recall

Healthcare providers who use these catheters should stop using them and contact Applied Medical.  In November 2019, Applied Medical sent a notice to healthcare providers asking them to do the following:

  • Check inventory for recalled products
  • Complete a Recall Notification Confirmation Form
  • Indicate if the facility is returning catheters
  • Distributors should notify all facilities that received catheters of the recall
  • Return the Recall Notification to Applied Medical
  • Return all recalled products

These catheters have been under a recall since October 2019, so healthcare providers should not be actively using them.  Patients with questions or concerns should contact their healthcare provider.

How to Report Medical Device Adverse Events

If you experience an adverse event related to any medical device, it is important to report it to your healthcare provider, the manufacturer and the FDA.  Reporting an adverse event is important because it helps the manufacturer and FDA understand what is happening with the device.  These reports are often the catalyst for product recalls as well, which is important for protecting consumers.

Healthcare providers and consumers can report adverse events related to a medical device through MedWatch: The FDA Safety Information and Adverse Event Reporting Program.  You can complete this report online, by mail or fax.

Medical Device Recalls and Your Legal Rights

If you or someone you love has been injured due to a defective medical device, contact Drug and Device Watch.  You have certain legal rights as a consumer, and it is important that you know your rights and possible options you may have to take legal action.  You may have grounds to file a personal injury claim against the product manufacturer if your injury is caused by a defect in any of the following:

  • Design – A design defect may include a poorly designed product or a product that does not have adequate safety features.
  • Manufacturing – Defects during manufacturing are not intended, but it is up to the manufacturer to inspect their products and ensure safety. Manufacturing defects are defects that cause the device to deviate from the intended use.  For example, a tip that detaches may have been poorly manufactured.
  • Warning – Manufacturers must provide warnings on any product that could be dangerous to the user or subject. Medical devices and drugs must have warnings related to use, possible side effects and known hazards.

If you can prove to the court that your injury is due to a defect and that the manufacturer knew or should have known about the hazard, you may be eligible for compensation for your injuries and losses.

To find out more about your legal rights and possible legal options, contact Drug and Device Watch for a free legal consultation.  Our legal professionals will evaluate your situation and help determine if you do have an actionable claim.  To request your free consultation, call us at 1-888-458-6825.  You can also request more information or a consultation by completing our online form.