PulseSprayRecalls & reported problems across all models

We found 3 models of PulseSpray by Angiodynamics, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

PulseSpray recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 18, 2023Class IIOpen, Classified

   Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.

   Z-1010-2024 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗

PulseSpray models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PulseSpray H787125004040

  Catheter, continuous flush
  1 recall0 reports
• PulseSpray H787125004150

  Catheter, continuous flush
  1 recall0 reports
• PulseSpray H787125004230

  Catheter, continuous flush
  1 recall0 reports

Other Angiodynamics, Inc. products

• Soft-Vu54 models · 66 reports · 18 recalls
• Mini Stick MAX12 models · 2 reports · 12 recalls
• Smart Port CT36 models · 479 reports
• VenaCure EVLT15 models · 437 reports
• AccuVu9 models · 14 reports · 4 recalls
• DuraMax8 models · 23 reports · 3 recalls
• Solero4 models · 154 reports
• DuraFlow6 models · 8 reports · 2 recalls