Syringe, Balloon Inflation
FDA adverse event reports and recall history for syringe, balloon inflation (product code MAV), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 3,677
- Deaths
- 8
- Injuries
- 92
- Malfunctions
- 3,567
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-09-05Open, ClassifiedUnder Investigation by firm
Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
- 2024-12-20Open, ClassifiedComponent change control
20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.
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.
- 2024-12-20Open, ClassifiedComponent change control
20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
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.
- 2024-12-20Open, ClassifiedComponent change control
20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
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.
- 2024-12-20Open, ClassifiedComponent change control
20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.
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.
- 2014-12-29TerminatedDevice Design
Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures
Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure
- 2014-12-29TerminatedDevice Design
Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter
Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure
- 2014-07-22TerminatedProcess control
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
Perouse Medical in France initiated a voluntary recall of certain batches of Perouse FLAMINGO Inflations Devices due to a potential water-tightness default. The potential default could cause an air entry when the plunger is positioned around 20 mL.
- 2014-02-26TerminatedLabeling mix-ups
Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the balloon. The Everest 20atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20bars in 0.5 bar increments. The Everest 30atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 30bars in 0.5 bar increments. The manometers are accurate to within +/- 3% of the gauges full scale. The device is a sterile, single use device and is not implanted; it also does not come in direct contact with the patient. This product is packaged in an inner and outer Tyvek /poly layer pouch.
Incorrect master label.
- 2010-08-25TerminatedPackaging process control
Medtronic Everest 20 Disposable Inflation Device, AC2200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.
Product sterility may be compromised due to breach of package seal integrity.
Monitor syringe, balloon inflation automatically
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