Indeflator 1000186-115Recalls & reported problems

Summary

The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 08717648015274), received between Dec 21, 2020 and Nov 27, 2024 — classified as 1 injury, 123 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (122 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Nov 6, 2024Open, Classified

   Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.

   Z-0733-2025 · Root cause: Component change control · FDA record ↗

2. Mar 11, 2022Open, Classified

   Due to an increase in complaint trend for leaks and intermittent/loose connections.

   Z-0922-2022 · Root cause: Component change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 124 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THREE INDEFLATOR DEVICES, WHEN ATTEMPTING TO PULL NEGATIVE, BUBBLES APPEARED IN THE INDEFLATOR TUBE. THE INDEFLATOR DEVICES WERE NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20793329 ↗
• MalfunctionNov 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE INDEFLATOR, AN AIR BUBBLE WAS NOTED IN THE DEVICE. THERE WAS NO REPORTED DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER INDEFLATOR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20669233 ↗
• MalfunctionNov 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE INDEFLATOR, AN AIR BUBBLE WAS NOTED IN THE DEVICE. THERE WAS NO REPORTED DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER INDEFLATOR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20669192 ↗
• MalfunctionNov 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE INDEFLATOR DEVICE NEGATIVE PRESSURE WAS NOT WORKING AND AIR BUBBLES WERE NOTED IN THE INDEFLATOR DEVICE. THE INDEFLATOR WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20669146 ↗
• MalfunctionNov 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION THE INDEFLATOR WAS NOTED TO HAVE A LEAK AS THE DEVICE WAS NOT ABLE TO HOLD NEGATIVE WHEN CONNECTED DIRECTLY TO A BALLOON PRIOR TO BEING USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER INDEFLATOR WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668088 ↗
• MalfunctionNov 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE INDEFLATOR DEVICE NEGATIVE PRESSURE WAS NOT WORKING AND AIR BUBBLES WERE NOTED IN THE INDEFLATOR DEVICE. THE INDEFLATOR WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668062 ↗
• MalfunctionNov 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION THE INDEFLATOR WAS NOTED TO HAVE A LEAK AS THE DEVICE WAS NOT ABLE TO HOLD NEGATIVE WHEN CONNECTED DIRECTLY TO A BALLOON PRIOR TO BEING USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER INDEFLATOR WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20667790 ↗
• MalfunctionNov 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION THE INDEFLATOR WAS NOTED TO HAVE A LEAK AS THE DEVICE WAS NOT ABLE TO HOLD NEGATIVE WHEN CONNECTED DIRECTLY TO A BALLOON PRIOR TO BEING USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER INDEFLATOR WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20667472 ↗
• MalfunctionNov 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE INDEFLATOR DEVICE AIR BUBBLES WERE NOTED; THEREFORE, THE INDEFLATOR DEVICE WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20666000 ↗
• MalfunctionNov 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE INDEFLATOR DEVICE AIR BUBBLES WERE NOTED; THEREFORE, THE INDEFLATOR DEVICE WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20665913 ↗
• MalfunctionNov 8, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THREE INDEFLATOR DEVICES, WHEN ATTEMPTING TO PULL NEGATIVE, BUBBLES APPEARED IN THE INDEFLATOR TUBE. THE INDEFLATOR DEVICES WERE NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20646203 ↗
• MalfunctionNov 8, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION THE INDEFLATOR WAS NOTED TO HAVE A LEAK AS THE DEVICE WAS NOT ABLE TO HOLD NEGATIVE WHEN CONNECTED DIRECTLY TO A BALLOON PRIOR TO BEING USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER INDEFLATOR WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20646027 ↗
• MalfunctionNov 8, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THREE INDEFLATOR DEVICES, WHEN ATTEMPTING TO PULL NEGATIVE, BUBBLES APPEARED IN THE INDEFLATOR TUBE. THE INDEFLATOR DEVICES WERE NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20645845 ↗
• MalfunctionNov 8, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION THE INDEFLATOR WAS NOTED TO HAVE A LEAK AS THE DEVICE WAS NOT ABLE TO HOLD NEGATIVE WHEN CONNECTED DIRECTLY TO A BALLOON PRIOR TO BEING USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER INDEFLATOR WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20645734 ↗
• MalfunctionNov 8, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION THE INDEFLATOR WAS NOTED TO HAVE A LEAK AS THE DEVICE WAS NOT ABLE TO HOLD NEGATIVE WHEN CONNECTED DIRECTLY TO A BALLOON PRIOR TO BEING USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER INDEFLATOR WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20645253 ↗
• MalfunctionNov 8, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION THE INDEFLATOR WAS NOTED TO HAVE A LEAK AS THE DEVICE WAS NOT ABLE TO HOLD NEGATIVE WHEN CONNECTED DIRECTLY TO A BALLOON PRIOR TO BEING USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER INDEFLATOR WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20644087 ↗
• MalfunctionNov 7, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE 20/30 PRIORITY PACK INDEFLATOR WITH ROTATING HEMOSTATIC VALVE WAS CONNECTED DIRECTLY TO AN UNSPECIFIED BALLOON WHEN A LEAK WAS NOTED. AIR WAS NOTED TO ENTER THROUGH THE SEALING OF THE HOSE, AS SEEN BY AIR BUBBLES, AND THE PRESSURE ON THE GAUGE DECREASED. ANOTHER INDEFLATOR WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632181 ↗
• MalfunctionNov 7, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE INDEFLATOR DEVICE DID NOT VACUUM AND AIR ENTERED THROUGH THE SEALED HOSE INTO THE INDEFLATOR BODY. THERE AS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631677 ↗
• MalfunctionNov 5, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE INDEFLATOR WAS CONNECTED DIRECTLY TO THE BALLOON AND DOES NOT CREATE A VACUUM AND AIR ENTERS THE DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20614850 ↗
• MalfunctionNov 5, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN CONNECTED DIRECTLY TO A BALLOON, THE INDEFLATOR DOES NOT CREATE A VACUUM AND AIR ENTERS THE DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20614247 ↗
• MalfunctionNov 1, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE INDEFLATOR BUBBLES WERE PRESENT AS THE DEVICE COULD NOT HOLD NEGATIVE PRESSURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20591706 ↗
• MalfunctionNov 1, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PROCEDURE THE INDEFLATOR DEVICE LET AIR ENTER THE DEVICE AND BUBBLES COULD BE SEEN. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20591612 ↗
• MalfunctionNov 1, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PROCEDURE THE INDEFLATOR DEVICE LET AIR ENTER THE DEVICE AND BUBBLES COULD BE SEEN. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20591573 ↗
• MalfunctionNov 1, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE INDEFLATOR BUBBLES WERE PRESENT AS THE DEVICE COULD NOT HOLD NEGATIVE PRESSURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20591558 ↗
• MalfunctionNov 1, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE INDEFLATOR BUBBLES WERE PRESENT AS THE DEVICE COULD NOT HOLD NEGATIVE PRESSURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20591528 ↗