Indeflator 1000185Recalls & reported problems
Abbott Vascular Inc. · PLUS 30 PRIORITY PACK Accessory Kit includes INDEFLATOR PLUS 30 Inflation Device 30 atm 10 cc / Rotating Hemostatic Valve .096 " / Guide Wire Introducer / Torque Device · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Abbott Indeflator balloon inflation device has 131 reports. Most involve no patient, and many describe leaks or a stopcock that disconnects while the balloon is inflated. The reports mention no deaths and no injuries. There is 1 open recall, started in March 2022, over an increase in complaints about leaks and loose connections.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 131
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 08717648013607), received between Jun 27, 2017 and Feb 24, 2022 — classified as 131 malfunctions.
The most frequently reported specific device problem is “Inaccurate Information” (108 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
- 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 · FDA record ↗
Most reported problems
Device problems
- Inaccurate Information108
- Leak/Splash21
- Loose or Intermittent Connection2
- Device Misassembled During Manufacturing /Shipping1
- Nonstandard Device1
Patient problems
- No Patient Involvement109
- No Consequences Or Impact To Patient19
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 25 most recent of 131 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED BASED ON A COMMENT THAT DURING THE PROCEDURE THE INDEFLATOR WAS NOTED TO BE PULLING AIR INTO THE CHAMBER. A LEAK SEEMS TO BE COMING FROM THE TUBING THAT CONNECTS TO THE CHAMBER. THE INDEFLATOR WAS CHANGED TO A NEW INDEFLATOR TO 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 13595088 ↗MalfunctionFeb 10, 2022Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THROUGH A GENERAL COMMENT THAT WHILE ATTEMPTING TO INFLATE THE BALLOON, THE STOPCOCK WITH THE LIGHT BLUE HANDLE WOULD DISCONNECT FROM THE BALLOON. 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 13508627 ↗MalfunctionFeb 10, 2022Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT WHILE ATTEMPTING TO INFLATE THE BALLOON, THE STOPCOCK WITH THE LIGHT BLUE HANDLE WOULD DISCONNECT FROM THE BALLOON. THEREFORE, THE STOPCOCK WAS REPLACED. 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 13508350 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684188 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684179 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684177 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684174 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684169 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684168 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684167 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684161 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684159 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684158 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684154 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684149 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684142 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684138 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684126 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684112 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684096 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684095 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684075 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684070 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684032 ↗MalfunctionJul 12, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT 88 EXPIRED UNITS OF PPAK DEVICES WERE SENT TO THE ACCOUNT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7684029 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.