Pronto® V4 extraction catheter 4006Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M20640060), received between Jun 7, 2016 and Nov 23, 2016 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 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.

• InjuryNov 23, 2016Break; Entrapment of Device

  PATIENT BROUGHT TO CATH LAB FOR EMERGENT CARDIAC CATH. LAD 100 PERCENT OCCLUDED AND BARE METAL STENT PLACED. A CLOT WAS THEN EXTRACTED FROM DIAGONAL ARTERY. AS CATHETER WAS PULLED BACK, PART BROKE AND REMAINED IN THE LAD. PATIENT TRANSFERRED TO OPERATING ROOM FOR BYPASS OF LAD AND DIAGONAL ARTERY. SURGICAL INTERVENTION WAS PERFORMED. DIAGNOSIS OR REASON FOR USE: STEMI. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO. EVENT REAPPEARED AFTER REINTRODUCTION: NO.

  Patient problems: Foreign Body In Patient

  MAUDE report 6124447 ↗
• MalfunctionJun 7, 2016Disconnection; Material Separation; Material Separation

  THE DISTAL TIP OF THE PRONTO V4 CATHETER BECAME DISCONNECTED FROM THE REST OF THE CATHETER WHILE BEING USED IN THE PERIPHERAL VASCULAR SYSTEM, ACTUAL LOCATION NOT SPECIFIED. THE TIP WAS ABLE TO BE RETRIEVED FROM THE BODY AND NO PATIENT HARM ENSUED. THE PRONTO WAS USED TO ASPIRATE CLOT IN THE DISTAL LEFT LEG DURING AN EMERGENT CASE. WHEN THE OPERATOR WENT TO REMOVE THE WIRE, THE DISTAL 7-10 CM OF THE CATHETER WAS SHEARED OFF. HOWEVER, THE FACT THAT IT WAS SHEARED OFF WAS NOT NOTICED AT THAT TIME AND THE TIP WAS LEFT IN THE PATIENT. THE NEXT DAY, THE PHYSICIAN WENT IN AS PLANNED TO FIX THE LEG. DURING THE PROCEDURE, THE PHYSICIAN HAD A BALLOON DOWN AND NOTICED THAT THERE WAS AN EXTRA RADIOPAQUE MARKER. THE PHYSICIAN WAS ABLE TO SNARE A 8 CM SEGMENT OF THE PRONTO.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5704244 ↗

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