A Fetch 2 catheter recall has been announced for Boston Scientific’s Fetch 2 Aspiration catheters. These thrombectomy catheters are used during procedures to remove small blood clots from coronary arteries. The U.S. Food and Drug Administration (FDA) has labeled the recall as a Class I, the agency’s most serious classification of recall, which is used when there is a reasonable probability that use of the device could cause serious adverse health complications or death. Affected patients and their families may be eligible to pursue compensation with the help of a defective medical device lawyer.
For more information, contact Attorney Group today. Our consultations are free, confidential and without any obligation on your part. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated attorney who can assist you throughout the legal process.
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Fetch 2 Catheter Recall Includes Over 21,155 Devices
Boston Scientific, the manufacturer of the device, announced the recall on March 22, 2016. As part of the recall, all affected healthcare facilities were advised to discontinue use of all Fetch 2 catheters immediately and return unused product to Boston Scientific. Because Boston Scientific acquired the Fetch 2 catheter product line from Bayer Medical Care Inc., all recalled inventory is packaged and labeled as Bayer product.
The UPN codes associated with the Fetch 2 catheter recall include:
- FETCH2 US 109400-001
- FETCH2 OUS 109400-002
- FETCH2 CANADA 109400-003
- FETCH2 JAPAN 109400-004
- FETCH2 EU 109400-005
According to fiercemedicaldevices.com, Boston Scientific issued a statement cautioning that patients who have already undergone a thrombectomy with the recalled device are not at risk and that there haven’t been any reports of injury or death. But the company added that the most “severe potential outcome” of breakage is that device fragments could obstruct an artery, thereby potentially obstructing blood flow and requiring additional surgical intervention for removal.
The device was manufactured between June 11, 2014 and February 19, 2016. There are currently 21,155 devices on the market subject to the recall.
How a Fetch 2 Catheter Recall Attorney 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.
Patients who are injured by a defective Fetch 2 Aspiration catheter may be entitled to compensation for damages, including:
- Medical expenses
- The permanency of the injury
- Pain, suffering, and mental anguish
- Loss of income or ability to work
If a patient dies from complications related to a defective catheter, family members may be entitled to compensation for the wrongful death of their loved one, including:
- Conscious pain and suffering of a loved one prior to death
- Pain, suffering, and mental anguish from the loss of a loved one
- Funeral expenses
Patients who have suffered severe complications from Fetch 2 Aspiration catheters, as well as the families of those who have died as a result of complications with the device, are encouraged to seek the advice of a Fetch 2 catheter recall lawyer to learn more about their rights and remedies.
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