PRONTO IPN913531Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841156100230), received between Sep 23, 2020 and Jun 10, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2024Material Separation; Device Damaged by Another Device; Material Separation; Device Damaged by Another Device

  PATIENT EMERGENTLY CAME TO CATH LAB FOR STEMI. ANGIO SHOWED THROMBUS AND IN-STENT RESTENOSIS IN PREVIOUS LAD STENT PLACED (B)(6) 2024. BALLOON ANGIOPLASTY WAS PERFORMED. POST BALLOON ANGIOPLASTY, ANGIO SHOWED RESIDUAL THROMBUS. PRONTO WAS ADVANCED AND THROMBECTOMY WAS PERFORMED. POST THROMBECTOMY, THE PREVIOUS LAD STENT WAS NOTED TO BE EXTRACTED AND ATTACHED TO THE PRONTO DEVICE AT THE TIP OF THE FEMORAL SHEATH. ATTEMPTED EXTRACTION THROUGH THE RIGHT FEMORAL SHEATH WAS UNSUCCESSFUL. THE STENT BECAME DETACHED FROM THE PRONTO DEVICE BUT REMAINED ON THE WIRE. LEFT FEMORAL ACCESS WAS GAINED TO FINISHED THE STEMI PROCEDURE AND PLACE NEW STENT TO LAD. FURTHER ATTEMPTS TO REMOVE THE PRONTO DEVICE/ STENT INCLUDING REMOVING FEMORAL SHEATH FOR ANOTHER, WERE UNSUCCESSFUL AND CV SURGERY WAS CONSULTED FOR SURGICAL CUT DOWN. CONTINUED ATTEMPTS TO REMOVE PRONTO DEVICE. PRONTO WAS REMOVED, BUT THE TIP OF THE PRONTO WAS MISSING. MANUAL PRESSURE WAS APPLIED TO THE RIGHT FEMORAL ACCESS. THE MISSING TIP OF THE PRONTO DEVICE MADE ITS WAY OUT OF THE FEMORAL ARTERY ONTO THE TABLE. PATIENT SENT TO SURGERY. CV SURGERY REMOVED THE STENT IN ENTIRETY VIA CUTDOWN OF THE FEMORAL ARTERY. PATIENT IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19498227 ↗
• InjuryOct 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: PRONTO WAS USED IN HEAVILY CALCIFIED PERIPHERAL ARTERY. PRONTO TIP "BROKE OFF" DURING WITHDRAWAL. HAD TO USE A SNARE TO CAPTURE THE SEVERED PRONTO TIP. PATIENT BROUGHT BACK 3 DAYS LATER FOR THROMBECTOMY AND EMBOLECTOMY. IMPROVING BUT GUARDED CONDITION.

  Patient problems: Foreign Body Embolism

  MAUDE report 12703557 ↗
• MalfunctionJun 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: PRONTO CATHETER TIP BROKE OFF DURING THE PROCEDURE. MULTIPLE ATTEMPTS WERE MADE TO RECEIVE ADDITIONAL INFORMATION: INFORMATION RECEIVED FROM SITE: AT THIS TIME, I AM ONLY ALLOWED TO INFORM YOU THAT THE TIP OF THE CATHETER DID BREAK OFF DURING A PROCEDURE. PROCEDURE OUTCOME IS UNKNOWN, AND IF MEDICAL INTERVENTION WAS REQUIRED IS ALSO UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12060042 ↗
• InjurySep 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: PATIENT WAS UNDERGOING TIBIAL ANGIOPLASTY AND EXTRACTION OF THROMBUS. THE PRONTO V4 WAS PLACED OVER A AN .014 GUIDEWIRE AND AN EXTRACTION WAS PERFORMED. THE PRONTO WAS FLUSHED AND PLACED BACK OVER THE .014 WIRE BUT BECAME JAMMED ON THE WIRE. THE OPERATOR WASN'T ABLE TO PASS THE PRONTO FURTHER INTO THE PATIENT OR RETRIEVE IT OVER THE WIRE. THE CATHETER WAS PULLED AND SPLIT ON THE WIRE, LEAVING A PORTION STUCK ON THE GUIDEWIRE. THIS PORTION COULD NOT BE MOVED AND HAD TO BE GRASPED WITH A SURGICAL MOSQUITO TO HOLD IT TO REMOVE IT FROM THE GUIDEWIRE. THE REMAINING PART OF THE CATHETER THEN CAME OFF THE GUIDEWIRE IN PIECES, AND THE PROCEDURE WAS CONTINUED WITH A SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10574988 ↗

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