BioSentry® ARecalls & reported problems
Merit Medical Systems, Inc. · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450808122), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (3 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Pneumothorax1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Activation, Positioning or Separation Problem
CUSTOMER REPORTS THE OLD STYLE PLUG NOT ALLOWING THE PLUG TO GO INTO THE INTRODUCER PROPERLY. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24735017 ↗MalfunctionMar 30, 2026Activation, Positioning or Separation Problem
CUSTOMER REPORTS THE GEL PLUG DID NOT DEPLOY. THE PRODUCT WAS THROWN AWAY AND A NEW ONE WAS OPENED. NO PATIENT HARM. NO ADDITIONAL DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24718011 ↗InjuryMar 30, 2026Activation, Positioning or Separation Problem
THE CUSTOMER REPORTS THE PHYSICIAN HAD FINISHED TAKING ALL BIOPSY SAMPLES AND THEY WERE READY TO DEPLOY THE BIOSENTRY PLUG. THEY NOTICED THE PATIENT ALREADY HAD A PNEUMO SO THEY WERE READY TO DEPLOY THE PLUG AND FINISH THE CASE. THEY OPENED UP ONE BIOSENTRY PLUG AND NOTICED THE PUSHER WOULD NOT ADVANCE THROUGH THE ADAPTOR SO IT COULD NOT DEPLOY. THEY OPENED UP ANOTHER BIOSENTRY PLUG OF THE SAME LOT, BUT NOTICED THIS ONE WAS NOT ABLE TO ADVANCE ALL THE WAY THROUGH THE ADAPTOR EITHER. AT THIS POINT THEY OPENED UP AN OLDER LOT THEY HAD ON HAND TO COMPLETE THE PROCEDURE. THE PATIENT ALSO REQUIRED A BLOOD PATCH. NO ADDITIONAL DETAILS PROVIDED.
Patient problems: Pneumothorax
MAUDE report 24717433 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.