Indeflator 1003327Recalls & reported problems

Summary

The FDA's MAUDE database contains 722 adverse event reports that list this exact device (DI 08717648013973), received between Aug 5, 2016 and Jun 3, 2026 — classified as 3 injuries, 719 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (658 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-0732-2025 · 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-0923-2022 · Root cause: Component change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 722 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA). THE INDEFLATOR WAS USED AND FLUID WAS NOTED TO BE LEAKING AND THE NEEDLE PRESSURE DECREASING. ANOTHER INDEFLATOR WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25374472 ↗
• MalfunctionMay 5, 2026Leak/Splash; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE COPILOT WOULD NOT FLUSH BACK AND THE BLEEDBACK CONTROL SEAL LEAKED DURING THE PROCEDURE. A NEW COPILOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 25084497 ↗
• MalfunctionMay 1, 2026Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. A 20/30 PRIORITY PAK INDEFLATOR WAS UNABLE TO INFLATE A NON-ABBOTT STENT ABOVE 8 ATM. AN ADDITIONAL 20/30 PRIORITY PAK WAS USED TO COMPLETE THE PROCEDURE. 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 25058173 ↗
• MalfunctionApr 15, 2026Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE CO-PILOT DEVICE WAS NOTED TO BE LEAKING WHILE USING THE DEVICE WITH MULTIPLE UNSPECIFIED GUIDE WIRES (GW) THROUGH THE HEMOSTATIC VALVE. THE PROCEDURE WAS COMPLETED WITH CO-PILOT DEVICE. THERE WAS 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 24888805 ↗
• MalfunctionApr 15, 2026Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS FOR OPTICAL COHERENCE TOMOGRAPHY (OCT) OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE CO-PILOT BLEED BACK CONTROL VALVE WAS BEING USED IN THE PROCEDURE; HOWEVER, THE VALVE LEAKED DURING THE OCT INJECTION. ANOTHER COPILOT BBCV WAS USED TO CONTINUE THE PROCEDURE. THERE WAS 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 24887851 ↗
• MalfunctionApr 14, 2026Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE CO-PILOT DEVICE WAS BEING USED IN THE PROCEDURE; HOWEVER, THE DEVICE WAS NOTED TO BE LEAKING. ANOTHER CO-PILOT WAS USED TO CONTINUE THE PROCEDURE. THERE WAS 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 24878623 ↗
• MalfunctionMar 19, 2026Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) AND LEFT CIRCUMFLEX ARTERIES WITH MILD TORTUOSITY. DURING THE PROCEDURE TWO CO-PILOT INDEFLATORS WERE BEING USED; HOWEVER, THE TUBING ON ONE OF THE INDEFLATORS BECAME DETACHED DURING USE. THEREFORE, ANOTHER INDEFLATOR WAS USED TO CONTINUE THE PROCEDURE. THERE WAS 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 24645775 ↗
• MalfunctionMar 3, 2026Loose or Intermittent Connection

  SUBSEQUENT TO THE INITIALLY FILED REPORTS, AN ADDITIONAL COPILOT WAS RECEIVED. THE DEVICE SHOWED SIGNS OF USE AND FAILED TO MAINTAIN A SECURE CONNECTION DURING FUNCTIONAL TESTING. THE ACCOUNT DID NOT REPORT ANY ISSUES WITH THIS DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495476 ↗
• MalfunctionFeb 23, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT THE COPILOT WOULD NOT CONNECT TO THE CONTRAST DELIVERY SYSTEM. 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 24420657 ↗
• MalfunctionDec 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE POSTERIOR DESCENDING ARTERY (PDA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE INDEFLATOR LOSES PRESSURE AND DOES NOT INFLATE THE BALLOON/STENT. 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 23878200 ↗
• MalfunctionDec 16, 2025Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  SUBSEQUENT TO THE INITIALLY FILED REPORTS, THE PROCEDURE DESCRIPTION WAS UPDATED. IT WAS REPORTED IN A GENERAL COMMENT THAT THE COPILOT DID NOT SCREW IN PROPERLY. THERE WERE NO ADVERSE PATIENT EFFECTS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 23822297 ↗
• MalfunctionDec 16, 2025Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED IN A GENERAL COMMENT THAT THE COPILOT DID NOT SCREW IN PROPERLY AND LEAKED DURING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 23821941 ↗
• MalfunctionDec 16, 2025Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED IN A GENERAL COMMENT THAT THE COPILOT DID NOT SCREW IN PROPERLY AND LEAKED DURING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 23821836 ↗
• MalfunctionDec 16, 2025Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED IN A GENERAL COMMENT THAT THE COPILOT DID NOT SCREW IN PROPERLY AND LEAKED DURING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 23821803 ↗
• MalfunctionDec 16, 2025Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED IN A GENERAL COMMENT THAT THE COPILOT DID NOT SCREW IN PROPERLY AND LEAKED DURING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 23821732 ↗
• MalfunctionSep 17, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE INDEFLATOR WAS ATTEMPTED TO BE INFLATED TO 12 BAR BUT THE GAUGE OF PRESSURE SLOWLY WENT DOWN AND COULD NOT HOLD THE PRESSURE. THE DEVICE WAS CONNECTED DIRECTLY TO THE BALLOON. NO AIR BUBBLE WAS SEEN. MANY ATTEMPTS WERE MADE BUT THE GAUGE STILL WENT DOWN. A NEW NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 23079439 ↗
• MalfunctionSep 8, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO INFLATE THE BALLOON CATHETER WITH THE INDEFLATOR HOWEVER WHEN PRESSURIZED TO 25 ATMOSPHERES (ATM), THE GAUGE PRESSURE SLOWLY DROPPED AND COULD NOT HOLD AT 25 ATM. A NON-ABBOTT INDEFLATOR WAS USED TO 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 22993395 ↗
• MalfunctionSep 8, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO INFLATE THE BALLOON CATHETER WITH THE INDEFLATOR HOWEVER WHEN PRESSURIZED TO 25 ATMOSPHERES (ATM), THE GAUGE PRESSURE SLOWLY DROPPED AND COULD NOT HOLD AT 25 ATM. A NON-ABBOTT INDEFLATOR WAS USED TO 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 22993271 ↗
• MalfunctionSep 8, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO INFLATE THE BALLOON CATHETER WITH THE INDEFLATOR HOWEVER WHEN PRESSURIZED TO 12 ATMOSPHERES (ATM), THE GAUGE PRESSURE SLOWLY DROPPED AND COULD NOT HOLD AT 12 ATM. A NON-ABBOTT INDEFLATOR WAS USED TO 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 22993263 ↗
• MalfunctionSep 8, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO INFLATE THE BALLOON CATHETER WITH THE INDEFLATOR HOWEVER WHEN PRESSURIZED TO 12 ATMOSPHERES (ATM), THE GAUGE PRESSURE SLOWLY DROPPED AND COULD NOT HOLD AT 12 ATM. A NON-ABBOTT INDEFLATOR WAS USED TO 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 22993226 ↗
• MalfunctionAug 26, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PROCEDURE THE INDEFLATOR IN THE PPAK 20/30 WITH COPILOT WAS OBSERVED TO HAVE AIR IN THE GAUGE AND LOSING PRESSURE. A NEW INDEFLATOR WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT 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 22899192 ↗
• MalfunctionMar 4, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 80% STENOSED. WITH A BALLOON DILATATION CATHETER CONNECTED, THE PHYSICIAN TRIED TO CLOSE THE CAP OF THE COPILOT IN THE PRIORITY PACK 20/30 WITH COPILOT, BUT FLUID WAS STILL LEAKING FROM THE BLEEDBACK CONTROL SEAL. A NON-ABBOTT INFLATION DEVICE WAS USED TO 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 21518535 ↗
• MalfunctionMar 4, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS RIGHT CORONARY ARTERY. THE COPILOT IN PRIORITY PACK 20/30 WITH COPILOT WAS TURNED TIGHT, HOWEVER, FLUID WAS OBSERVED TO BE LEAKING FROM THE BLEEDBACK CONTROL. A NEW INFLATION DEVICE ALONG WITH A NON-ABBOTT ROTATING HEMOSTASIS VALVE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 21517720 ↗
• MalfunctionNov 14, 2024Leak/Splash; Physical Resistance/Sticking; Leak/Splash; Physical Resistance/Sticking

  A STERILE INDEFLATOR DEVICE WAS RETURNED. DURING FUNCTIONAL TESTING OF THE INDEFLATOR, RESISTANCE WAS FELT WHEN PULLING THE HANDLE. THERE WAS A SOUND OF ROD SLIDING THROUGH THE HALF NUTS WHEN THE HANDLE WAS BEING PULLED BACK AND FORTH. THE DEVICE FAILED AT VACUUM TEST. THE DEVICE WAS NOT USED IN A PROCEDURE AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689100 ↗
• MalfunctionNov 14, 2024Leak/Splash; Physical Resistance/Sticking; Leak/Splash; Physical Resistance/Sticking

  A STERILE INDEFLATOR DEVICE WAS RETURNED. DURING FUNCTIONAL TESTING OF THE INDEFLATOR, RESISTANCE WAS FELT WHEN PULLING THE HANDLE. THERE WAS A SOUND OF ROD SLIDING THROUGH THE HALF NUTS WHEN THE HANDLE WAS BEING PULLED BACK AND FORTH. THE DEVICE FAILED AT VACUUM TEST. THE DEVICE WAS NOT USED IN A PROCEDURE AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689064 ↗