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EverCross™ AB35W07120135 (UDI 00643169974180)Recalls & reported problems

Ev3, Inc · PTA AB35W07120135 EVERCROSS 035 V08 · Class 2

All models of EverCross (114)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169974180), received between Jan 31, 2023 and Jan 31, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 18, 2026.

Most reported problems

Device problems

  • Burst Container or Vessel1
  • Detachment of Device or Device Component1
  • Difficult to Remove1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • InjuryJan 31, 2023Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

    A PHYSICIAN WAS USING AN EVERCROSS PTA BALLOON DURING THE TREATMENT OF A 40MM CALCIFIED LESION IN THE COMMON FEMORAL ARTERY (CFA). THE ARTERY WAS 7-9MM IN DIAMETER AND THE DEGREE OF TORTUOSITY WAS MILD AND CALCIFICATION WAS SEVERE. A 6FR NON MEDTRONIC SHEATH WAS USED. EMBOLIC PROTECTION WAS NOT USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE BALLOON WAS INFLATED USING A NON MEDTRONIC INFLATION DEVICE AND CONTRAST/HEPARIN/SALINE MIX 50/50. IT WAS REPORTED INITIAL TREATMENT WAS AT SITE OF LEFT DISTAL SFA AND LEFT CFA THROUGH RIGHT CFA ACCESS AND UP AND OVER SHEATH. DIAGNOSTIC IMAGES TAKEN AND CSI ATHERECTOMY PERFORMED OF AFOREMENTIONED LESIONS. COMING BACK ACROSS ILIAC BIFURCATION THE PHYSICIAN INSERTED 7MM X 120MM BARD 035 PTA CATHETER TO TREAT LESIONS IN BILATERAL COMMON ILIAC ARTERY BY INFLATING A SINGLE BALLOON ACROSS CARINA IN BOTH ILIACS SIMULTANEOUSLY. THE NON MDT BALLOON RUPTURED AND WAS REMOVED. THE EVERCROSS BALLOON WAS THEN INSERTED AND TREATMENT WAS INITIATED IN SAME MANNER DESCRIBED ABOVE. THE BALLOON WAS INFLATED ONE TIME AT NOMINAL PRESSURE AND RUPTURED AT 7ATM AND AN ATTEMPTED WAS MADE TO REMOVE THE BALLOON.  A CIRCUMFERENTIAL/ RADIAL RUPTUR

    Patient problems: Insufficient Information

    MAUDE report 16272270 ↗

Other Catheter, percutaneous devices

All Catheter, percutaneous devices →

Sources and updates

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