Indeflator 1000184Recalls & reported problems

Summary

The FDA's MAUDE database contains 155 adverse event reports that list this exact device (DI 08717648013591), received between Sep 8, 2016 and Feb 4, 2026 — classified as 155 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (127 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-0730-2025 · 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-0921-2022 · Root cause: Component change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 155 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MILDLY TORTUOUS MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 75% STENOSED. WHEN INFLATING AND DEFLATING THE INDEFLATOR 20/30, THE GAUGE WOULD NOT ROTATE, AND PRESSURE COULD NOT BE APPLIED. THE INDEFLATOR WAS CONNECTED TO A CORONARY BALLOON. LEAKING WAS ALSO NOTED INSIDE THE INDEFLATOR. A NEW UNSPECIFIED 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 24262193 ↗
• MalfunctionMay 1, 2025Leak/Splash; Physical Resistance/Sticking; Leak/Splash; Physical Resistance/Sticking

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). A NON-ABBOTT STENT WAS DEPLOYED IN THE PROXIMAL RCA WITH THE INDEFLATOR. RESIDUAL STENOSIS PROXIMAL TO THE FIRST STENT WAS NOTED; THEREFORE, ANOTHER NON-ABBOTT STENT WAS ADVANCED AND PLACED IN THE TARGET LESION. THE PHYSICIAN NOTICED THAT THE INDEFLATOR NEED MORE ROTATION THAN USUAL TO ACHIEVE PRESSURE GAUGE MOVEMENT. THE DEVICE WAS INFLATED TO 18 ATMOSPHERES (ATM) WHEN IT WAS NOTED THERE WAS HALF CONTRAST HALF AIR FILLED IN THE BALLOON WHILE INFLATION. THE BALLOON WAS DEFLATED AND THE SYSTEM WAS PULLED OUT; HOWEVER, THE STENT DISLODGED IN THE OSTIAL RCA. THE PHYSICIAN SUSPECTED THE INDEFLATOR DID NOT WORK PROPERLY THEREFORE A NON-ABBOTT INDEFLATOR WAS USED TO ACHIEVE APPOSITION OF THE DISLODGED STENT AT OSTIAL RCA. 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 21942169 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). A 20/30 INDEFLATOR WAS ATTEMPTED TO BE USED HOWEVER THE PRESSURE GAUGE WAS NOTED TO NOT INCREASE WHEN INFLATING THE CONNECTED DEVICE. THEREFORE THE INDEFLATOR WAS REPLACED WITH A NEW 20/30 INDEFLATOR AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644844 ↗
• MalfunctionMar 17, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, HEAVILY TORTUOUS RIGHT CORONARY ARTERY. THE 20/30 INDEFLATOR PRESSURE WOULD NOT INCREASE DURING THE PROCEDURE. AN UNSPECIFIED 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 21624199 ↗
• MalfunctionFeb 6, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. THE BALLOON CATHETER WAS ADVANCED TO THE LESION HOWEVER WHEN ATTEMPTING TO INFLATE, THE INDEFLATOR DID NOT INCREASE PRESSURE. A NEW 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 21321235 ↗
• MalfunctionJan 31, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE INDEFLATOR WAS CONNECTED DIRECTLY TO THE BALLOON AND LEAKED DURING DEFLATION AS SEEN BY THE GAUGE NEEDLE PRESSURE DECREASING. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER INDEFLATOR WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21284877 ↗
• MalfunctionDec 13, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY. THE 20/30 INDEFLATOR COULD NOT MAINTAIN PRESSURE WHEN ATTEMPTING TO INCREASE PRESSURE TO 30 PSI DURING THE PROCEDURE. A SECOND INDEFLATOR WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926397 ↗
• MalfunctionNov 26, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. WHEN ATTEMPTING TO INFLATE A 2.5X20MM NON-ABBOTT BALLOON, WHICH WAS CONNECTED DIRECTLY TO A 20/30 INDEFLATOR; THE PRESSURE GAUGE WOULD NOT INCREASE AND A WATER LEAK FROM THE INDEFLATOR WAS OBSERVED WITHIN THE PRESSURE GAUGE. NO VISIBLE CRACKS WERE NOTED ON THE GAUGE OR FACEPLATE. A NEW 20/30 INDEFLATOR 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 20785150 ↗
• MalfunctionNov 25, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT CIRCUMFLEX ARTERY. WHEN ATTEMPTING TO INFLATE A 2.0 X 15 MM NON-ABBOTT BALLOON USING A 20/30 INDEFLATOR THE PRESSURE GAUGE WOULD NOT INCREASE AND A WATER LEAK FROM THE INDEFLATOR WAS OBSERVED WITHIN THE PRESSURE GAUGE. A NEW 20/30 INDEFLATOR 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 20776352 ↗
• MalfunctionOct 31, 2024Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY. THE INDEFLATOR WAS CONNECTED DIRECTLY TO A NON-ABBOTT BALLOON AND DURING INFLATION, THE GAUGE OF THE INDEFLATOR WOULD NOT INCREASE AND WATER WAS SEEN LEAKING FROM THE INDEFLATOR NEAR THE PRESSURE GAUGE. A NEW INDEFLATOR 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 20578833 ↗
• MalfunctionSep 17, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE THE INDEFLATOR DEVICE A LEAK WAS SUSPECTED AS THE INDEFLATOR DID NOT WORK. 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 20240470 ↗
• MalfunctionAug 22, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING FUNCTIONAL TESTING, THE INDEFLATOR DEVICE LEAKED. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20035854 ↗
• MalfunctionAug 22, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING FUNCTIONAL TESTING, THE INDEFLATOR DEVICE LEAKED. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20033501 ↗
• MalfunctionAug 22, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING FUNCTIONAL TESTING, THE INDEFLATOR DEVICE LEAKED. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20033479 ↗
• MalfunctionAug 22, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING FUNCTIONAL TESTING, THE INDEFLATOR DEVICE LEAKED. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032738 ↗
• MalfunctionAug 22, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING FUNCTIONAL TESTING, THE INDEFLATOR DEVICE LEAKED. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032652 ↗
• MalfunctionAug 21, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING FUNCTIONAL TESTING, THE INDEFLATOR DEVICE LEAKED. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015827 ↗
• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNKNOWN VESSEL. REPORTEDLY THE 20/30 INDEFLATOR WAS USED TO INFLATE A NC TREK BALLOON DILATATION CATHETER (BDC), HOWEVER DURING DEFLATION IT WAS NOTED THAT THE INDEFLATOR DID NOT DEFLATE NORMALLY. THE DEVICE WAS REPLACED WITH ANOTHER INDEFLATOR AND THE PROCEDURE WAS COMPLETED. 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 19916644 ↗
• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). REPORTEDLY A INDEFLATOR 20/30 WAS USED TO INFLATE A XIENCE SIERRA, HOWEVER DURING DEFLATION IT WAS NOTED THAT THE INDEFLATOR DID NOT DEFLATE NORMALLY. THE INDEFLATOR WAS REPLACED WITH ANOTHER INDEFLATOR AND THE PROCEDURE WAS COMPLETED. 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 19916615 ↗
• MalfunctionAug 2, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PROCEDURE, A 20/30 PRIORITY PACK INDEFLATOR WAS CONNECTED DIRECTLY TO A BALLOON HUB AND DID NOT HOLD PRESSURE WHEN INFLATING. ANOTHER UNSPECIFIED INDEFLATOR WAS USED. 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 19896897 ↗
• MalfunctionJun 13, 2024Leak/Splash; Physical Resistance/Sticking; Leak/Splash; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA) WITH MILD CALCIFICATION AND MILD TORTUOSITY. A 4.5X24 MM NON-ABBOTT STENT WAS DEPLOYED USING THE INDEFLATOR WITHOUT ISSUES. THERE WAS RESIDUAL STENOSIS PROXIMALLY TO THE FIRST STENT WAS NOTED. ANOTHER 4.5X8 MM NON-ABBOTT STENT WAS INTRODUCED FOR THE RESIDUAL STENOSIS; HOWEVER, IT WAS NOTED THAT THE INDEFLATOR NEEDED MORE ROTATION THAN USUAL TO ACHIEVE PRESSURE GAUGE MOVEMENT. THE NON-ABBOTT STENT WAS DEPLOYED BUT HALF CONTRAST HALF AIR FILLED THE BALLOON DURING INFLATION. THE BALLOON WAS DEFLATED AND THE SYSTEM WAS PULLED OUT BUT FOUND THE STENT WAS DISLODGED TO OSTIAL RCA. ANOTHER NON-ABBOTT INFLATOR WAS USED TO ACHIEVE WALL APPOSITION OF THE DISLODGED STENT AT OSTIAL RCA. ANOTHER 4.5X12 MM NON-ABBOTT STENT WAS DEPLOYED PROXIMALLY TO THE FIRST STENT, UP TO 16 ATM. FINAL ANGIOGRAM SHOWED NO RESIDUAL STENOSIS. 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 19533504 ↗
• MalfunctionJun 11, 2024Leak/Splash; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19512943 ↗
• MalfunctionJun 3, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE INDEFLATOR LEAKED DURING DEFLATION. ANOTHER INDEFLATOR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED 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 19453249 ↗
• MalfunctionApr 22, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE 20/30 INDEFLATOR WAS NOTED TO HAVE A WATER LEAK FROM WITHIN THE PRESSURE GAUGE WHEN ATTEMPTING TO INFLATE A 2.75X15MM NON-ABBOTT BALLOON. A NEW 20/30 INDEFLATOR WAS USED TO INFLATE SAME BALLOON SUCCESSFULLY. A 3.5X32MM NON-ABBOTT STENT WAS IMPLANTED AND POST DILATATED WITH 3.5X15MM BALLOON. 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 19157656 ↗
• MalfunctionApr 2, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. DURING PRE-DILATATION, THE INDEFLATOR WAS NOTED TO HAVE A LEAK IN THE PRESSURE GAUGE HOUSING. ANOTHER 20/30 INDEFLATOR WAS USED TO CONTINUE THE PROCEDURE WITH THE SAME DILATATION BALLOON. 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 19022554 ↗