A voluntary recall was issued for the max-core disposable core biopsy instrument for specific product code/lot number combinations.The affected product code/lot number combinations 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.A root cause investigation and field action determination was conducted as a result of an increase in complaints for failure to fire, firing problem, and failure to obtain samples.The investigation included an extensive manufacturing review, risk documentation review for the three reported malfunctions, and evaluations performed on the returned devices.The root cause for the increase in complaints was related to mold maintenance that was performed on the cannula over-mold for mold 3.That maintenance had the unintended consequence of impacting product performance in specific low frequency use situations.The change made to mold 3 increased the spacing between the locking and unlocking mechanisms of the device, resulting in a reduction in stored energy within the device.This, in combination with the density of the tissue being biopsied, can occasionally result in issues where the device does not fully fire when the trigger is pressed (i.E.Only the stylet fires).All lots manufactured after the maintenance on mold 3 was performed are included in the scope of the recall.All reported complaints from the affected product code/lot number combinations that are possibly related to the firing issue have been classified as failure to fire, firing problem, or failure to obtain samples.This reported complaint is from an affected lot number that was reported for one of these firing issues.(expiry date: 06/2022).The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Device not returned.
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