Affirm Lateral Arm Upright Biopsy Accessory ASY-03723Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15420045506817), received between Jun 16, 2017 and Jun 16, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 reports).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 7, 2017Class IITerminated

   The firm is implementing a product correction involving its Affirm Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. This impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. There are no known instances of illness or injury.

   Z-0351-2018 · Root cause: Component change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2017Failure to Align; Device Operates Differently Than Expected; Failure to Align; Device Operates Differently Than Expected

  DURING THE INITIAL BIOPSY APPLICATIONS TRAINING (PRIOR TO FIRST PATIENT USE), OUR APPLICATION SPECIALIST VALIDATED THE SPRING LOADED BIOPSY NEEDLE (BARD MAGNUM, NON VACUUM ASSISTED BIOPSY DEVICE). TO DO THIS THEY FOLLOWED A DEFINED PROCEDURE USING A TARGETING PHANTOM (PHANTOM WITH NEEDLE TIP INSIDE). AT THE END OF THE TEST, THE TIP OF THE BIOPSY NEEDLE NEEDS TO BE ALIGNED WITH THE NEEDLE TIP OF THE TARGETING PHANTOM. DURING THIS VALIDATION PROCESS THEY HAVE NOTICED THE BIOPSY NEEDLE WAS NOT ALIGNED WITH THE TARGETING PHANTOM. IT WAS OFF FOR APPROX. 2MM WHEN THE LATERAL ARM WAS INSTALLED ON THE LEFT HAND SIDE (BLUE SIDE).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6648560 ↗
• MalfunctionJun 16, 2017Failure to Align; Device Operates Differently Than Expected; Failure to Align; Device Operates Differently Than Expected

  DURING THE INITIAL BIOPSY APPLICATIONS TRAINING (PRIOR TO FIRST PATIENT USE), OUR APPLICATION SPECIALIST VALIDATED THE SPRING LOADED BIOPSY NEEDLE (BARD MAGNUM, NON VACUUM ASSISTED BIOPSY DEVICE). TO DO THIS THEY FOLLOWED A DEFINED PROCEDURE USING A TARGETING PHANTOM (PHANTOM WITH NEEDLE TIP INSIDE). AT THE END OF THE TEST, THE TIP OF THE BIOPSY NEEDLE NEEDS TO BE ALIGNED WITH THE NEEDLE TIP OF THE TARGETING PHANTOM. DURING THIS VALIDATION PROCESS THEY HAVE NOTICED THE BIOPSY NEEDLE WAS NOT ALIGNED WITH THE TARGETING PHANTOM. IT WAS OFF FOR APPROX. 2MM WHEN THE LATERAL ARM WAS INSTALLED ON THE LEFT HAND SIDE (BLUE SIDE).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6648550 ↗
• MalfunctionJun 16, 2017Failure to Align; Device Operates Differently Than Expected; Failure to Align; Device Operates Differently Than Expected

  DURING THE INITIAL BIOPSY APPLICATIONS TRAINING (PRIOR TO FIRST PATIENT USE), OUR APPLICATION SPECIALIST VALIDATED THE SPRING LOADED BIOPSY NEEDLE (BARD MAGNUM, NON VACUUM ASSISTED BIOPSY DEVICE). TO DO THIS THEY FOLLOWED A DEFINED PROCEDURE USING A TARGETING PHANTOM (PHANTOM WITH NEEDLE TIP INSIDE). AT THE END OF THE TEST, THE TIP OF THE BIOPSY NEEDLE NEEDS TO BE ALIGNED WITH THE NEEDLE TIP OF THE TARGETING PHANTOM. DURING THIS VALIDATION PROCESS THEY HAVE NOTICED THE BIOPSY NEEDLE WAS NOT ALIGNED WITH THE TARGETING PHANTOM. IT WAS OFF FOR APPROX. 2MM WHEN THE LATERAL ARM WAS INSTALLED ON THE LEFT HAND SIDE (BLUE SIDE).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6648534 ↗