PRONTO IPN913539Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841156100315), received between Jun 22, 2022 and Jul 11, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: IN THE PCI PROCEDURE, THE THROMBUS WAS AT AROUND PROXIMAL MIDDLE OF LAD, 6F, 3.0 GUIDING CATHETER, GUIDE WIRE AND 6FPRONTO LP WERE USED TO REMOVE THE THROMBUS. AFTER THE THROMBUS WAS EXTRACTED, ON THE DEVICE PREPARING TABLE, THE USER JUST DETACHED THE SYRINGE FROM THE CATHETER AND FOUND THE CATHETER SHAFT AND Y-ADAPTER HUB WERE SEPARATED. THE PCI PROCEDURE WENT FINE AND THERE WAS NO IMPACT TO THE PATIENT.ADDITIONAL INFORMATION ON 19JUN2022: THE DEVICE WAS COMPLETELY OUT OF THE PATIENT'S VESSEL WHEN THE SEPARATION OCCURRED. IT WAS ON THE TABLE THAT THE USER WAS ABOUT TO FILTER THE BLOOD AND THROMBUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14983309 ↗
• MalfunctionJun 22, 2022Separation Problem; Separation Problem

  AS REPORTED, ABOUT 5-6 INCHES OF IT BROKE OFF WHILE DOING AN INTERVENTION, BUT THANKFULLY WE WERE ABLE TO RETRIEVE THE ENTIRE COMPONENT THAT DETACHED ITSELF. ADDITIONAL INFORMATION STATED THAT PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14776231 ↗