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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter repair kit
Regulation Description Percutaneous, implanted, long-term intravascular catheter.
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 CodePWR
Regulation Number 880.5970
Device Class 2

MDR Year MDR Reports MDR Events
2026 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 7 7
Fluid/Blood Leak 2 2
Obstruction of Flow 2 2
Material Split, Cut or Torn 2 2
Patient-Device Incompatibility 2 2
Material Separation 2 2
Material Deformation 1 1
Device Damaged Prior to Use 1 1
Detachment of Device or Device Component 1 1
Material Rupture 1 1
Migration 1 1
Insufficient Device Problem Information 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Leak/Splash 1 1
Computer Software Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
Anaphylactoid / Anaphylaxis 2 2
Nausea 1 1
Pain 1 1
Skin Discoloration 1 1
Swelling/ Edema 1 1
Thrombosis/Thrombus 1 1
Insufficient Information 1 1
Vasculitis 1 1
Diaphoresis 1 1
Foreign Body In Patient 1 1
Dyspnea 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL, LLC I Jun-13-2026
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