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.
FDA Recall Z-0044-2018 · Posted None
Recalling FirmBard Peripheral Vascular Inc
Recall StatusTerminated
Product CodeKNW
Date Initiated2017-09-22
Date Terminated2018-09-27
Product Quantity110,550 units
Reason for Recall
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
US, Australia, Canada, Europe, Middle East, Africa, Latin America, Asia Pacific
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.