PRONTO IPN913530Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841156100223), received between May 17, 2019 and Jul 11, 2022 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathJul 11, 2022Entrapment of Device; Entrapment of Device

  AS REPORTED: PRONTO V4 5.5 FR USED IN AN ACUTE STEMI FOR THROMBECTOMY. PATIENT DIED BEFORE SUCCESSFUL TREATMENT OF THE INFARCTION. PATIENT PRESENTED WITH ACUTE MI. TRANSCATHETER THROMBECTOMY ATTEMPTED WITH PRONTO V4 5.5 FR. WHILE ATTEMPTING TO WITHDRAW PRONTO CATHETER THE CATHETER WAS REPORTED TO BE STUCK IN A PREVIOUSLY PLACED CORONARY STENT. CHEST COMPRESSIONS WERE PERFORMED AS PATIENT BEGAN TO DECLINE. IT IS NOT CLEAR WHETHER THIS WAS IN RELATION TO THE ORIGINAL CAUSE OF THE MI OR DUE TO COMPLICATIONS OF HAVING A CATHETER STUCK IN THE CORONARY. LATER THE PRONTO WAS REMOVED AND IT WAS FOUND THAT THE CORONARY STENT HAD BEEN DISLODGED. ADDITIONAL ON 20JUN2022 - THE ACCOUNT REPORTED THAT THE PRONTO CATHETER WAS STUCK IN A STENT THAT WAS PLACED APPROX. 5 YEARS AGO. ADDITIONAL INFORMATION ON 21JUN2021: PLAVIX WAS STOPPED BEFORE DUE TO HIP SURGERY. PATIENT HAD PRESENTED WITH A STEMI ON 16TH INTO 17TH (11PM - 1AM). THROMBUS WAS IN CIRCUMFLEX MID DISTAL ARTERY. THE PREVIOUSLY PLACED STENT SIZE WAS 3.0MM AND HAD IN-STENT RESTENOSIS. THE PRONTO V4 CATHETER WOULDN'T GO FORWARD OR BACK ONCE THEY ADVANCED THE CATHETER THE 3RD TIME AFTER TWO SUCCESSFUL PASSES. NITRO WAS GIVEN. A SECOND GUIDEWI

  Patient problems: Cardiac Tamponade

  MAUDE report 14983311 ↗
• MalfunctionMay 17, 2019Material Fragmentation; Material Fragmentation

  CUSTOMER REMOVED THE CATHETER AFTER ASPIRATING. ON THE BACK TABLE, AS THE CUSTOMER WAS FLUSHING THE ASPIRATE THROUGH THE FILTER BASKET, A LONG STRING OF WHAT APPEARS TO BE PLASTIC CAME OUT LONGITUDINALLY. NO PATIENT IMPACT OR INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8619806 ↗

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