Recall Z-0724-2020 ยท KNW Instrument, Biopsy
Bard Peripheral Vascular Inc
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.
| Date | Oct 25, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Equipment maintenance |
| Action | 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 |
| Quantity | 727,034 units |
| Distribution | Worldwide distribution - US Nationwide distribution and countries of Australia, Canada, Europe, Middle East, Africa, Latin America, Asia Pacific. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133948 | BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT Bard Peripheral Vascular, Inc., Feb 21, 2014 |