PRONTO IPN922584Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841156108977), received between Jul 11, 2023 and Jul 11, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

1 other recall cover devices cleared under the same FDA submission (K103405); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PRONTO CATHETER WOULD NOT ADVANCE INTO THE VESSEL. ADDITIONAL INFORMATION: DURING AN ANGIOGRAM THROUGH THE LEFT FEMORAL. THE PHYSICIAN WAS UNABLE TO ADVANCE THE PRONTO INTO THE PATIENTS VESSEL THE PHYSICIAN CONFIRMED THAT THERE WAS NO HARM OR INJURY TO THE PATIENT FROM THE DEVICE. THERE WAS NO REPORTED DEFECTS OR KINKS TO THE CATHETER. THE PATIENT WAS TRANSFERRED TO HOSPITAL TO PERFORM A BYPASS TO THE PERONEAL ARTERY BUT FAILED. THEY ARE REPORTED TO STILL BE IN HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17297224 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103405. One submission often covers many models, so check the product and lot details in each record.

• Z-2946-2011 · Jul 11, 2011 · Terminated
  Vascular Solutions, Pronto V4, Extraction Catheter, Sterilized using ethylene oxide, Rx Only. The following sizes/model numbers are affected: 5.5F( 4005), 6F(4006, 7F(4007, 8F(400