Indeflator 1000183Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648013584), received between Aug 1, 2017 and Sep 29, 2020 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 reports).

1 FDA recall record name this device's identifier, 1 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. Mar 11, 2022Open, Classified

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

   Z-0924-2022 · Root cause: Component change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2020Break; Break

  THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE OSTIUM OF THE LEFT ANTERIOR DESCENDING ARTERY AND THE LEFT MAIN ARTERY. THE HANDLE OF THE PLUS 30 INDEFLATOR BROKE INSIDE THE CHAMBER WHILE ATTEMPTING TO DEFLATE AN UNSPECIFIED BALLOON CATHETER. A SYRINGE WAS USED TO DEFLATE THE BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW INDEFLATOR. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10603163 ↗
• MalfunctionJul 17, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE OF THE INDEFLATOR PLUS 30, THERE WAS A LEAK OBSERVED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 Consequences Or Impact To Patient

  MAUDE report 10292354 ↗
• MalfunctionOct 30, 2017Leak/Splash

  IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), TWO PLUS 30 INDEFLATORS DID NOT MAINTAIN PRESSURE WHEN CONNECTED TO BALLOON CATHETERS. THE DEVICES WERE REPLACED WITH AN INDEFLATOR FROM ANOTHER LOT AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. ANALYSIS OF 3 RETURNED UNUSED/STERILE DEVICES NOTED LEAKS WITH THE STOPCOCKS. ROOT CAUSE ANALYSIS DETERMINED THAT THE ISSUE REPORTED WITH THE INDEFLATORS IN THIS CASE WAS LIKELY DUE TO A LEAK IN THE STOPCOCKS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6988904 ↗
• MalfunctionOct 30, 2017Leak/Splash

  IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), TWO PLUS 30 INDEFLATORS DID NOT MAINTAIN PRESSURE WHEN CONNECTED TO BALLOON CATHETERS. THE DEVICES WERE REPLACED WITH AN INDEFLATOR FROM ANOTHER LOT AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. ANALYSIS OF 3 RETURNED UNUSED/STERILE DEVICES NOTED LEAKS WITH THE STOPCOCKS. ROOT CAUSE ANALYSIS DETERMINED THAT THE ISSUE REPORTED WITH THE INDEFLATORS IN THIS CASE WAS LIKELY DUE TO A LEAK IN THE STOPCOCKS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6988865 ↗
• MalfunctionOct 10, 2017Leak/Splash

  UNUSED/STERILE DEVICES WERE RETURNED FOR LEAK TESTING. ANALYSIS OF THE RETURNED STERILE DEVICES NOTED 3 OF THE STOPCOCKS LEAKED DURING FUNCTIONAL TESTING.

  Patient problems: No Patient Involvement

  MAUDE report 6939092 ↗
• MalfunctionOct 10, 2017Leak/Splash

  UNUSED/STERILE DEVICES WERE RETURNED FOR LEAK TESTING. ANALYSIS OF THE RETURNED STERILE DEVICES NOTED 3 OF THE STOPCOCKS LEAKED DURING FUNCTIONAL TESTING.

  Patient problems: No Patient Involvement

  MAUDE report 6939070 ↗
• MalfunctionOct 10, 2017Leak/Splash

  UNUSED/STERILE DEVICES WERE RETURNED FOR LEAK TESTING. ANALYSIS OF THE RETURNED STERILE DEVICES NOTED 3 OF THE STOPCOCKS LEAKED DURING FUNCTIONAL TESTING.

  Patient problems: No Patient Involvement

  MAUDE report 6939004 ↗
• MalfunctionAug 1, 2017Leak/Splash

  SUBSEQUENT TO THE INITIAL FILED MEDWATCH REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THE INDEFLATOR WAS PREPPED PER STANDARD PROCEDURE; THE INDEFLATOR WAS CONNECTED TO THE STRAIGHT PORT, A SYRINGE WAS CONNECTED TO THE SIDE PORT, AND NEGATIVE PRESSURE WAS PULLED. THE LEAK AS NOTED WHEN THE INDEFLATOR WAS PRESSURIZED WITH A STARTING PRESSURE OF APPROXIMATELY 6 ATMOSPHERES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6757760 ↗