Encore 40 Inflation Device QL2540Recalls & reported problems
Atrion Medical Products, Inc. · Inflation Device Atrion Part Number 96505: 25ml, 40atm · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00856877002445), received between Aug 27, 2025 and Jul 28, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Zero” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Zero1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50058413 ↗MalfunctionAug 27, 2025Failure to Zero; Failure to Zero
IT WAS REPORTED THAT THE GAUGE FAILED TO ZERO. AN ENCORE 40 INFLATION DEVICE WAS SELECTED FOR SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE PROCEDURE, THE PRESSURE WAS LOWERED, BUT THE GAUGE DID NOT DROP TO ZERO. THE INDEFLATOR WAS REPLACED, AND THE BALLOON WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22901432 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.