QL Disposable Inflation Device QL® 2530 (REF BINF2530)Recalls & reported problems
Atrion Medical Products, Inc. · Inflation Device Atrion Part Number 96460: 25mL, 30atm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00856877002414), received between Dec 8, 2022 and Jun 5, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
- Output Problem1
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.
MalfunctionJun 5, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED, THE DEVICE PACKAGING OF THE URETHRAL DILATOR HAD BLACK FOREIGN MATERIAL. THE PACKAGE WAS UNOPENED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19469639 ↗MalfunctionDec 8, 2022Output Problem; Output Problem
THE CUSTOMER REPORTED THE BALLOON BURST DURING A PROCEDURE. MAXIMUM ATMOSPHERE 17 WAS USED AND THE BALLOON DID NOT FOLD OUT PROPERLY. THE USER SUSPECTED THE INFLATION DEVICE WAS INCORRECT. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS FOR THE BALLOON INFLATION DEVICE. THE BALLOON (MODEL BPCN1015) IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15945808 ↗
Other Dilator, Urethral devices
- Bard® Urologist's Tray 123400C. R. Bard, Inc. · DILATOR, URETHRAL1 recall8 reports
- UroMax Ultra Kit M0062251210Boston Scientific Corporation · DILATOR, URETHRAL1 recall6 reports
- UroMax Ultra Kit M0062251220Boston Scientific Corporation · DILATOR, URETHRAL1 recall5 reports
- UroMax Ultra Kit M0062251370Boston Scientific Corporation · DILATOR, URETHRAL1 recall4 reports
- UroMax Ultra Kit M0062251200Boston Scientific Corporation · DILATOR, URETHRAL1 recall3 reports
- UroMax Ultra Kit M0062251290Boston Scientific Corporation · DILATOR, URETHRAL1 recall2 reports
- UroMax Ultra Kit M0062251310Boston Scientific Corporation · DILATOR, URETHRAL1 recall2 reports
- UroMax Ultra Kit M0062251240Boston Scientific Corporation · DILATOR, URETHRAL1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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