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MONOPTY 121210Recalls & reported problems

Bard Peripheral Vascular, Inc. · MONOPTY® Disposable Core Biopsy Instrument, 22mm penetration depth, 12g x 10cm · Class 2

All models of MONOPTY (13)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741084560), received between Aug 10, 2021 and Aug 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (1 report).

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 16, 2026.

Most reported problems

Device problems

  • Device Damaged Prior to Receipt by User1
  • Tear, Rip or Hole in Device Packaging1
  • Unsealed Device Packaging1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 10, 2021Unsealed Device Packaging; Device Damaged Prior to Receipt by User; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Device Damaged Prior to Receipt by User; Tear, Rip or Hole in Device Packaging

    IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY DAMAGED DUE TO HEAT. IT WAS FURTHER REPORTED THAT STERILE BARRIER ALLEGEDLY BREACHED. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12299910 ↗

Other INSTRUMENT, BIOPSY devices

All INSTRUMENT, BIOPSY devices →

Sources and updates

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