PTDClass IIImplant
Subcutaneous Implanted Apheresis Port
General Hospital · 21 CFR 880.5965
A subcutaneous implanted apheresis port is a prescription device intended for patient therapies requiring repeated access to the vascular system and long-term therapeutic apheresis
MDR events173All time
Recalls0All time
Registered firms9Currently listed
510(k) clearances3All time
Recent MDR events
173 adverse event reports on file
- APHERESIS PORT ACCESS SYSTEMFeb 11, 2026InjuryC.r. Bard, Inc. (basd) -30062607403006260740-2026-00760
- APHERESIS PORT ACCESS SYSTEMDec 13, 2025InjuryC.r. Bard, Inc. (basd) -30062607403006260740-2025-09623
- APHERESIS PORTNov 4, 2025InjuryC.r. Bard, Inc. (basd) -30062607403006260740-2025-08311
- APHERESIS PORTNov 4, 2025InjuryC.r. Bard, Inc. (basd) -30062607403006260740-2025-08310
- APHERESIS PORTOct 28, 2025InjuryC.r. Bard, Inc. (basd) -30062607403006260740-2025-08053
- APHERESIS PORTOct 27, 2025InjuryC.r. Bard, Inc. (basd) -30062607403006260740-2025-08014
- APHERESIS PORTOct 22, 2025InjuryC.r. Bard, Inc. (basd) -30062607403006260740-2025-07935
- APHERESIS PORTOct 22, 2025InjuryC.r. Bard, Inc. (basd) -30062607403006260740-2025-07936
- APHERESIS PORTOct 22, 2025InjuryC.r. Bard, Inc. (basd) -30062607403006260740-2025-07937
- APHERESIS PORTOct 10, 2025InjuryC.r. Bard, Inc. (basd) -30062607403006260740-2025-07628
Event type breakdown
Malfunction101
Injury71
Death1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
9 firms currently registered for this product code
510(k) clearances
3 clearances for this product code