Indeflator 1000186Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 08717648013614), received between Sep 23, 2019 and Sep 18, 2026 — classified as 56 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (44 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-0731-2025 · 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50822617 ↗
• MalfunctionOct 3, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT TO MILDLY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. THE INDEFLATOR IN PPAK 20/30 WAS NOTED TO BE LOSING PRESSURE WHEN ATTEMPTING TO INFLATE AN UNSPECIFIED DEVICE. AN UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23212249 ↗
• MalfunctionFeb 10, 2025Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNKNOWN VESSEL. A 20/30 INDEFLATOR PRIORITY PACK ACCESSORY KIT (PPAK), WAS ATTEMPTED TO BE USED TO INFLATE AN UNKNOWN BALLOON; HOWEVER, THE GAUGE DID NOT PROVIDE ATMOSPHERES AND THE BALLOON COULD NOT BE INFLATED. THE INDEFLATOR WAS REPLACED WITH ANOTHER SYRINGE DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21345267 ↗
• MalfunctionApr 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CIRCUMFLEX ARTERY. THE 20/30 INDEFLATOR BEGAN TO LOSE PRESSURE ONCE IT REACHED TO 12 ATMOSPHERES DURING THE PROCEDURE. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19097308 ↗
• MalfunctionApr 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED CIRCUMFLEX ARTERY. THE 20/30 INDEFLATOR BEGAN TO LOSE PRESSURE ONCE IT REACHED TO 12 ATMOSPHERES DURING THE PROCEDURE. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19097176 ↗
• MalfunctionApr 8, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY. THE INDEFLATOR FAILED TO INFLATE THE BALLOON WHEN APPLYING PRESSURE. ANOTHER INDEFLATOR WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068044 ↗
• MalfunctionJan 16, 2024Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE INDEFLATOR WAS USED TO INFLATE A NON-COMPLIANT (NC) BALLOON AT 12 ATMOSPHERES (ATMS) WHEN IT STARTED TO LOSE PRESSURE AND THEN THE GAUGE BROKE APART SEPARATING FROM THE HOUSING. ANOTHER INDEFLATOR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 18521912 ↗
• MalfunctionDec 4, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION AND USE OF THE INDEFLATOR DEVICE, THE HOUSING OF THE DEVICE WAS LEAKING. WHEN ATTEMPTING TO PRESSURIZE THE INDEFLATOR, IT WOULD REACH A CERTAIN PRESSURE (6 ATMOSPHERES) AND THEN IT WOULD LOSE PRESSURE AS IF IT WERE LEAKING OR SUCKING AIR. THE BOTTOM OF THE DEVICE WAS LEAKING. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW INDEFLATOR WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18260518 ↗
• MalfunctionApr 25, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION AND MILD TORTUOSITY. DURING THE PROCEDURE, THE BALLOON WAS INTENDED TO BE INFLATED AND THE INDEFLATOR WAS BROUGHT TO 12 ATMOSPHERES AND IT WORKED CORRECTLY. HOWEVER, WHEN INFLATION WAS ATTEMPTED AGAIN THE INDEFLATOR DID NOT EXCEED 10 ATMOSPHERES. ANOTHER DEVICE WAS USED WHICH REACHED 18 ATMOSPHERES. 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 16809827 ↗
• MalfunctionJan 9, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PROCEDURE WAS TO TREAT A CALCIFIED SUPERFICIAL FEMORAL ARTERY. THE INDEFLATOR WAS ATTACHED TO A BALLOON CATHETER. WHEN NEGATIVE PRESSURE WAS APPLIED TO THE INDEFLATOR, AIR WAS NOTICED IN THE INDEFLATOR. THE INDEFLATOR CONNECTIONS WERE INSPECTED FOR LEAKS AND REATTACHED TO THE BALLOON CATHETER. THE INDEFLATOR WOULD NOT HOLD PRESSURE, THE HANDLE KEPT SPINNING AND THE DIAL WOULD NOT GO UP. ANOTHER INDEFLATOR WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16126121 ↗
• MalfunctionDec 6, 2022Leak/Splash; Loose or Intermittent Connection; Improper or Incorrect Procedure or Method; Mechanical Jam; Leak/Splash; Loose or Intermittent Connection; Improper or Incorrect Procedure or Method; Mechanical Jam

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE INDEFLATOR WAS CONNECTED WITH A STOPCOCK.AND THE DEVICE LOCK DID NOT CLOSE PROPERLY. IT WAS NOTED TO HAVE A LEAK SINCE IT COULD NOT INFLATE THE BALLOON. ANOTHER INDEFLATOR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 15925669 ↗
• MalfunctionApr 1, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING PREPARATION THE THREE-WAY STOPCOCK OF A 20/30 INDEFLATOR WAS LOOSE AND COULD NOT BE TIGHTENED. THE INDEFLATOR WAS NOT USED WITH A PATIENT. ANOTHER INDEFLATOR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13973146 ↗
• MalfunctionApr 1, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING PREPARATION, THE THREE-WAY STOPCOCK OF THE INDEFLATOR PPAK 20/30 COULD NOT BE TIGHTENED FIRMLY. 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 13972758 ↗
• MalfunctionMar 24, 2022Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE STOPCOCK OF THE INDEFLATOR WAS NOT FULLY CONNECTED AND AIR ENTERED IN THE SYSTEM DURING USE. 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 13891876 ↗
• MalfunctionMar 24, 2022Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE STOPCOCK OF THE INDEFLATOR WAS NOT FULLY CONNECTED AND AIR ENTERED IN THE SYSTEM DURING USE. 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 13891369 ↗
• MalfunctionMar 23, 2022Break; Loose or Intermittent Connection; Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING PREPARATION PHASE OF THE INDEFLATOR, IT WAS NOTED THAT WHEN THE PHYSICIAN PULLED THE PLUNGER, IT WAS ALREADY LOOSE. THE INDEFLATOR FRACTURED/CRACKED BUT REMAINED IN ONE PIECE. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW DEVICE WAS OPENED AND USED TO SUCCESSFULLY COMPLETE 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 13862309 ↗
• MalfunctionMar 20, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING PREPARATION THE THREE-WAY STOPCOCK OF AT 20/30 INDEFLATOR WAS LOOSE AND COULD NOT BE TIGHTENED. THE INDEFLATOR WAS NOT USED ON THE PATIENT. IT IS UNKNOWN AT THIS TIME HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13835252 ↗
• MalfunctionMar 20, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING PREPARATION THE THREE-WAY STOPCOCK OF AT 20/30 INDEFLATOR WAS LOOSE AND COULD NOT BE TIGHTENED. THE INDEFLATOR WAS NOT USED ON THE PATIENT. IT IS UNKNOWN AT THIS TIME HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13835238 ↗
• MalfunctionMar 20, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING PREPARATION THE THREE-WAY STOPCOCK OF AT 20/30 INDEFLATOR WAS LOOSE AND COULD NOT BE TIGHTENED. THE INDEFLATOR WAS NOT USED ON THE PATIENT. IT IS UNKNOWN AT THIS TIME HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13835222 ↗
• MalfunctionMar 2, 2022Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. AN INDEFLATOR FROM THE 20/30 PRIORITY PAK WAS UNABLE TO INFLATE THE BALLOON AS THERE WAS A NOTED LEAK COMING FROM THE INDEFLATOR. ADDITIONALLY, IT WAS ALSO REPORTED THAT THE 3 WAY STOP COCK WAS UNABLE TO SCREW ON, AS IT KEPT ROTATING.. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656034 ↗
• MalfunctionMar 2, 2022Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. AN INDEFLATOR FROM THE 20/30 PRIORITY PAK WAS UNABLE TO INFLATE THE BALLOON AS THERE WAS A NOTED LEAK COMING FROM THE INDEFLATOR. ADDITIONALLY, IT WAS ALSO REPORTED THAT THE 3 WAY STOP COCK WAS UNABLE TO SCREW ON, AS IT KEPT ROTATING. THERE WAS 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 13655997 ↗
• MalfunctionFeb 25, 2022Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. AN INDEFLATOR FROM THE PRIORITY PAK WAS UNABLE TO INFLATE THE BALLOON AS THERE WAS A NOTED LEAK COMING FROM THE INDEFLATOR. ADDITIONALLY, IT WAS ALSO REPORTED THAT THE 3 WAY STOP COCK WAS UNABLE TO SCREW ON, AS IT KEPT TURNING. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE 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 13600065 ↗
• MalfunctionFeb 25, 2022Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. AN INDEFLATOR FROM THE PRIORITY PAK WAS UNABLE TO INFLATE THE BALLOON AS THERE WAS A NOTED LEAK COMING FROM THE INDEFLATOR. ADDITIONALLY, IT WAS ALSO REPORTED THAT THE 3 WAY STOP COCK WAS UNABLE TO SCREW ON, AS IT KEPT TURNING. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE 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 13600046 ↗
• MalfunctionFeb 25, 2022Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CIRCUMFLEX ARTERY. AN INDEFLATOR FROM THE PRIORITY PAK WAS UNABLE TO INFLATE THE BALLOON AS THERE WAS A NOTED LEAK COMING FROM THE INDEFLATOR. ADDITIONALLY, IT WAS ALSO REPORTED THAT THE 3 WAY STOP COCK WAS UNABLE TO SCREW ON, AS IT KEPT TURNING. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE 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 13599942 ↗
• MalfunctionFeb 22, 2022Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A FISTULA IN AN UNSPECIFIED ARTERY. A NON-ABBOTT DRUG-ELUTING BALLOON WAS ADVANCED IN THE PATIENT AND THE INDEFLATOR WAS CONNECTED TO THE BALLOON. THE PHYSICIAN WANTED TO PERFORM A LONG INFLATION AT 10 ATMOSPHERES (ATMS); HOWEVER, THE INDEFLATOR WOULD NOT HOLD PRESSURE AT 10 ATMS. ADDITIONALLY, A SLOW LEAK WAS OBSERVED AT THE CONNECTION. ANOTHER INDEFLATOR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 13579339 ↗