IndeflatorRecalls & reported problems across all models

We found 7 models of Indeflator by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 1,196 adverse event reports in the FDA's MAUDE database, received between Aug 5, 2016 and Sep 18, 2026 — classified as 4 injuries, 1,192 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (979 reports).

9 FDA recall records name at least one of these models by its device identifier, 9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Indeflator recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · FDA record ↗

2. 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 · Recall details · FDA record ↗

3. 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 · Recall details · FDA record ↗

4. 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 · Recall details · FDA record ↗

5. Mar 11, 2022Open, Classified

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

   Z-0925-2022 · Root cause: Component change control · names 2 of these models · Recall details · FDA record ↗

6. 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 · Recall details · FDA record ↗

7. 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 · Recall details · FDA record ↗

8. 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 · names 2 of these models · Recall details · FDA record ↗

9. 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 · Recall details · FDA record ↗

Most reported Indeflator problems

Indeflator models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Indeflator 1003327

  Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
  2 recalls722 reports
• Indeflator 1000184

  Syringe, balloon inflation
  2 recalls155 reports
• Indeflator 1000186-115

  Syringe, balloon inflation
  2 recalls124 reports
• Indeflator 1000185

  Syringe, balloon inflation
  1 recall131 reports
• Indeflator 1000186

  Syringe, balloon inflation
  2 recalls56 reports
• Indeflator 1000183

  Syringe, balloon inflation
  1 recall8 reports
• Indeflator 1000185-115

  Syringe, balloon inflation
  1 recall0 reports

Recent Indeflator adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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