Recall Z-0044-2018 ยท KNW Instrument, Biopsy
Bard Peripheral Vascular Inc
BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.
| Date | Sep 22, 2017 |
| Status | Terminated |
| Reason | During the review of May 2017 complaint data, a significant increase in MAX-CORE Disposable Core Biopsy Instrument complaints was observed for Failure to Prime, Failure to Fire, Failure to Obtain Sample, and Self-Activation. |
| Root cause | Device Design |
| Action | BPV sent a customer recall letter on September 22, 2017 to each of the US consignees via FedEx with proof of delivery notification. BPV will also initiate a recall for product outside the US in accordance with regulations of each country in which the product was distributed. |
| Quantity | 110,550 units |
| Distribution | US, 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 |