QL Locking Syringe Device QL38Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00856877002032), received between Sep 27, 2022 and Jan 26, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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.

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.

• MalfunctionJan 26, 2026Defective Device

  A COMPLAINT WAS RECEIVED ON 9/19/2025 REPORTING: "AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WITH A 29MM SAPIEN 3 VALVE, THE INDEFLATOR LOCKED UP AFTER INFLATION. THE BALLOON COULD NOT BE DEFLATED USING THE INDEFLATOR AND HAD TO BE DEFLATED MANUALLY.". A PCR WAS OPENED AND AN INVESTIGATION LAUNCHED TO DETERMINE THE POTENTIAL ROOT CAUSE AND WHETHER CORRECTIVE ACTION WAS NECESSARY. A SECOND COMPLAINT FROM THE SAME LOT WAS RECEIVED ON 11/07/2025 STATING: AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 29 MM SAPIEN 3 ULTRA RESILIA VALVE, WHILE DEPLOYING THE VALVE, THE INDEFLATOR WOULD NOT PULL NEGATIVE TO COME DOWN ON THE BALLOON. THE LOCKING MECHANISM WOULD NOT RELEASE THE THREADED PORTION OF THE INDEFLATOR PLUNGER. IT WAS CONFIRMED THAT THE ATRION QL38 WAS UNLOCKED WHEN TRYING TO PULL NEGATIVE TO DEFLATE THE BALLOON, BUT IT WOULD NOT RELEASE. THE INDEFLATOR WAS QUICKLY DISCONNECTED FROM THE DELIVERY SYSTEM, ALLOWING THE BALLOON TO PASSIVELY EMPTY. A 50 CC SYRINGE WAS QUICKLY ATTACHED TO THE DELIVERY SYSTEM STOPCOCK AND PULL

  Patient problems: Unspecified Heart Problem

  MAUDE report 24179841 ↗
• MalfunctionSep 27, 2022Fracture; Leak/Splash; Fracture; Leak/Splash

  A COMPLAINT WAS RECEIVED REPORTING: "AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING VALVE DEPLOYMENT OF A 29 MM SAPIEN 3 VALVE IN THE NATIVE AORTIC VALVE VIA TRANSFEMORAL APPROACH, THE ATRION QL38 INFLATION DEVICE CRACKED WITH APPROXIMATELY 3CC STILL IN THE INFLATION DEVICE. A 20CC SYRINGE WAS CONNECTED TO THE DELIVERY SYSTEM TO COMPLETE THE DEPLOYMENT. A SECOND ATRION QL38 WAS OPEN AND USED TO INSURE THE VALVE WAS FULLY INFLATED. CURRENTLY THE DEVICE IS WITH R&D FOR CT SCANNING, AND WE PLAN TO CONDUCT SIMILAR DIAGNOSTICS AS THE PREVIOUS INVESTIGATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15495497 ↗