BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire, Firing Problem, and Failure to Obtain Samples.

On 10/28/2019, the firm sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" Letter to customers via FedEx informing them the firm has identified MAX-CORE Disposable Core Biopsy Instruments that may be at risk of having firing issues. An example of a firing issue is where the device does not completely fire, resulting in the inability to obtain tissue samples. The firm also informed their customers that using the affected product will lead to a varying degree of user dissatisfaction or may be associated with a prolonged procedure or minor tissue injury or minor bleeding. Most often, a coaxial cannula is used and or the device is being used with ultrasound guidance, minimizing the risk of harm. Customer are instructed to: 1. Do not use or further distribute any affected product. 2. check all inventory locations within their institution for affected product code / lot number combinations listed in the recall notice. If they have further distributed any of the product code / lot numbers, to please immediately contact that location, advise them of the recall, forward these instructions and have them return the affected product to the Recalling Firm. 3. Please remove any identified product from your shelves. 4. If the affected products have been used, complete and return the attached Recall and Effectiveness Check Form indicating no product will be returned. Once the product affected by this recall has been removed from your inventory: 5. Fill out the Recall and Effectiveness Check Form. Be sure to state the quantities and lot numbers of each recalled product that you intend to return. It is extremely important that we receive this information. 6. Email the completed Recall And Effectiveness Check Form to the Recalling Firm or fax it to 1-800-994-6772. 7. Once the Recall and Effectiveness Check Form has been completed and emailed or faxed to 1-800-994-6772 and all information has been verified, the Customer Support Center will issue the customers a Return Au