Boston Scientific Aspiration Catheter Shattering and Causing Serious Injuries/Deaths
Boston Scientific Corporation is recalling the Fetch 2 Aspiration Catheter because the catheter shaft may break at various points along the device, before or during procedures. If breakage occurs while the device is in a patient, pieces of the catheter may block blood supply to the heart or blood vessels. This could result in the need for additional medical procedures, patient injury, or death.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injury or death.
The devices were in use from June 24, 2014 to March 11, 2016 nationwide and could still be in use if facilities have not yet removed them from their inventories. The device is intended to remove small blood clots from peripheral veins and coronary arteries to restore blood flow to the heart. This procedure is called a thrombectomy. Initially announced on March 22, 2016, the recall advised healthcare facilities to discontinue use of all Fetch 2 Aspiration Catheters. Boston Scientific acquired the product line from Bayer Medical and all recalled inventory is packaged and labeled as Bayer product. Your doctor may think it is a Bayer product and not the subject of this recall by Boston Scientific.
If you or a loved one underwent this procedure at any time since June 24, 2014, and were told that you had an incident of shaft breakage, you should contact us for more information. One of the possible results of shaft breakage is that fragments of the device could remain in the body, which could potentially obstruct blood flow and require additional surgery. Anyone who had this occur or who had to return for an additional procedure after the first surgery may have a claim.
For more information, please contact us.
For more online reports of this recall, see http://www.drugs.com/fda/fetch-2-aspiration-catheter-boston-scientific-recall-shaft-breakage-13859.html.