QL Disposable Inflation Device QL® 2530 (REF 96402)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00856877002025), received between Mar 15, 2019 and Jun 2, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  COMPLAINT DESCRIPTION: DURING THE TRANSFEMORAL TAVR PROCEDURE FOR A 26MM SAPIEN 3 VALVE, THREADED PLUNGER OF ATRION INFLATION DEVICE QL2530 PART NUMBER 96402 BROKE OFF. AFTER THE VALVE WAS DEPLOYED, THE OPERATOR PULLED THE PLUNGER TO DEFLATE THE BALLOON. THEN THE PLUNGER BROKE OFF AND SEPARATED FROM THE PISTON. THE BALLOON WAS DEFLATED ONLY -2ML. THE DEVICE WAS REPLACED WITH THE OTHER INFLATION DEVICE WHICH WAS USED FOR PRE-DILATION. AS THE RAPID PACING WAS EXECUTED FOR LONGER TIME, VENTRICULAR FIBRILLATION (VF) OCCURRED. DEFIBRILLATION AND CARDIAC MASSAGE WERE DONE AND ADRENALINE WAS GIVEN. THE BLOOD PRESSURE WAS BACK TO NORMAL AND THERE WAS NO OTHER COMPLICATION. THE PATIENT WAS RETURNED TO ICU. THE PHYSICIAN STATED THAT THE SITUATION COULD BE FATAL WHEN THE BALLOON COULD NOT BE DEFLATED. DESCRIPTION OF PROBLEM: A PHOTO OF THE COMPLAINT DEVICE WAS RECEIVED WITH THE COMPLAINT, WHICH REVEALS THAT THE BLACK PLUNGER COMPONENT OF THE BALLOON INFLATION SYRINGE SEPARATED FROM THE PISTON AND WAS REMOVED FROM THE DEVICE. THE PLUNGER TIP WHICH SNAP FITS AND LOCKS THE PLUNGER TO THE PISTON EXHIBITED AN INJECTION MOLDING DEFECT KNOW AS A SHORT OR NON-FILL. THIS SHORT OR NON-FILL MEANS THE PL

  Patient problems: Ventricular Fibrillation

  MAUDE report 10112641 ↗
• InjuryMar 15, 2019No Device Output; Improper or Incorrect Procedure or Method; No Device Output; Improper or Incorrect Procedure or Method

  AS REPORTED TO ATRION: DURING DEPLOYMENT OF A VALVE IN THE AORTIC POSITION, THE PHYSICIAN LOOKED AT THE PRESSURE READING ON THE ATRION DEVICE TO ENSURE AS TO NOT CAUSE AN ANNULAR RUPTURE. THE ATRION PRESSURE GAUGE DID NOT SHOW ANY PRESSURE READING, HOWEVER THE BALLOON AND VALVE WERE INFLATED. A LOT NUMBER WAS NOT REPORTED FOR THIS COMPLAINT, HOWEVER, VALVE SERIAL NUMBERS WERE PROVIDED TO ATRION. THE KITS THAT THE VALVE SERIAL NUMBERS WERE ASSOCIATED WITH CONTAINED INFLATION DEVICES FROM LOTS 96402244 AND 96402249. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE TWO LOTS INDICATED THAT THE DEVICES WERE MANUFACTURED UNDER NORMAL OPERATING PROCEDURES. ALL FINAL ASSEMBLY DEVICES WERE SAMPLED, INSPECTED, AND ACCEPTED PER (B)(4). THE DEVICE WAS NOT RETURNED SO A FUNCTIONAL INVESTIGATION COULD NOT BE CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOTS 96402244 AND 96402249 REVEALED EVERYTHING MET THE ACCEPTANCE CRITERIA. ADDITIONALLY ALL INFLATION DEVICES ARE 100% TESTED WITH ULTRA-HIGH PURITY NITROGEN GAS FOR FUNCTIONAL COMPLIANCE OF THE GAUGE, PRESSURE TESTED, AND VACUUM TESTED DURING MANUFACTURE. EACH DEVICE IS CHECKED FOR PROPER GAUGE ORIENTATION, GAUGE RESPONSIVENESS TO PRESSURE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8424304 ↗