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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device syringe, balloon inflation, exempt
Regulation Description Angiographic injector and syringe.
Definition This product code is the class II exempt counterpart of MAV, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Product CodePTM
Regulation Number 870.1650
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2023 3 3
2025 26 26
2026 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 29 29
Separation Problem 11 11
Inflation Problem 10 10
Material Separation 9 9
Failure to Deflate 3 3
Display or Visual Feedback Problem 3 3
Separation Failure 2 2
Gas/Air Leak 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 2 2
Contamination /Decontamination Problem 1 1
Unsealed Device Packaging 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Break 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 43 43
Insufficient Information 2 2
Unspecified Tissue Injury 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Laceration(s) 1 1
Cardiac Arrest 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Sep-05-2025
2 Merit Medical Systems, Inc. II Jan-16-2026
3 Merit Medical Systems, Inc. II Oct-11-2024
4 Merit Medical Systems, Inc. II Jul-29-2021
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