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PNGClass 2

Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

FDA adverse event reports and recall history for peritoneal, drainage catheter for refractory ascites, long-term indwelling (product code PNG), from the public MAUDE/AEMS corpus and the live FDA recall database.

Total reports
174
Deaths
2
Injuries
33
Malfunctions
139

Reports per year

17
18
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 20172026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

  • 2023-06-14Open, ClassifiedProcess control

    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only

    There is a potential that valve assemblies will not open. preventing fluid from draining.

  • 2023-06-14Open, ClassifiedProcess control

    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only

    There is a potential that valve assemblies will not open. preventing fluid from draining.

  • 2023-06-14Open, ClassifiedProcess control

    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only

    There is a potential that valve assemblies will not open. preventing fluid from draining.

  • 2023-06-14Open, ClassifiedProcess control

    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only

    There is a potential that valve assemblies will not open. preventing fluid from draining.

  • 2023-06-14Open, ClassifiedProcess control

    Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only

    There is a potential that valve assemblies will not open. preventing fluid from draining.

  • 2023-06-14Open, ClassifiedProcess control

    Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only

    There is a potential that valve assemblies will not open. preventing fluid from draining.

  • 2023-06-14Open, ClassifiedProcess control

    Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only

    There is a potential that valve assemblies will not open. preventing fluid from draining.

  • 2023-06-14Open, ClassifiedProcess control

    Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only

    There is a potential that valve assemblies will not open. preventing fluid from draining.

  • 2023-06-14Open, ClassifiedProcess control

    Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only

    There is a potential that valve assemblies will not open. preventing fluid from draining.

  • 2023-06-14Open, ClassifiedProcess control

    Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only

    There is a potential that valve assemblies will not open. preventing fluid from draining.

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