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SAVVY 435300LRecalls & reported problems

Cordis Corporation · PTA SAVVY SMALL VESSEL 3X10 · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032006207), received between Mar 9, 2019 and Mar 9, 2019 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Burst Container or Vessel1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionMar 9, 2019Burst Container or Vessel; Burst Container or Vessel

    AS REPORTED, THE BALLOON ON A SAVVY BALLOON CATHETER (PTA SMALL VESSEL 3X10) RUPTURED. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS CLINICALLY USED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8406356 ↗

Other Catheter, angioplasty, peripheral, transluminal devices

All Catheter, angioplasty, peripheral, transluminal devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.