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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device percutaneous sheath introducer kit
Regulation Description Catheter introducer.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOFL
Regulation Number 870.1340
Device Class 2

MDR Year MDR Reports MDR Events
2021 6 6
2022 5 5
2023 5 5
2025 7 7
2026 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 10 10
Fluid/Blood Leak 6 6
Break 4 4
Material Separation 3 3
Crack 3 3
Leak/Splash 3 3
Material Puncture/Hole 2 2
Fracture 2 2
Gas/Air Leak 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
Foreign Body In Patient 10 10
Embolism/Embolus 4 4
Hemorrhage/Blood Loss/Bleeding 3 3
Perforation of Vessels 2 2
Pain 2 2
Insufficient Information 2 2
Unspecified Tissue Injury 1 1
Occlusion 1 1
Laceration(s) 1 1
Unspecified Vascular Problem 1 1
Thrombosis/Thrombus 1 1
Loss of consciousness 1 1
Vascular Dissection 1 1
Liver Laceration(s) 1 1
Stroke/CVA 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL, LLC I Jun-13-2026
2 ARROW INTERNATIONAL, LLC II Apr-22-2026
3 Galt Medical Corporation II May-07-2025
4 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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