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POWERFLEX 4400622SRecalls & reported problems

Cordis US Corp. · POWERFLEXPRO 6MM22CM 80 · 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 20705032059630), received between Aug 7, 2020 and Aug 7, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Partial Blockage” (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

  • Partial Blockage1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionAug 7, 2020Partial Blockage; Partial Blockage

    AS REPORTED, A NON-CORDIS GUIDEWIRE CANNOT ADVANCED INTO THE LUMEN OF A 6MM X 22CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER TILL THE END. IT WAS COMPLETELY BLOCKED AND WAS NOT ABLE TO ADVANCE. THE NON-CORDIS GUIDEWIRE EXPERIENCED HEAVY FRICTION IN THE CATHETER LUMEN APPROXIMATELY AT FOUR-FIFTHS (4/5) OF THE LENGTH OF THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREP NORMALLY. THE DIFFICULTY WAS ENCOUNTERED WHILE LOADING THE BALLOON OVER THE GUIDE WIRE. THERE WERE NO VISIBLE KINKS/BENDS NOTED ON EITHER ONE OF THE DEVICES. THE CANNULA WIRE PORT OR GUIDEWIRE LUMEN WAS NOT OBSTRUCTED. THE INSERTION DIFFICULTY WAS POSSIBLY CAUSED BY A BLOCKAGE OF INJECTABLE MATERIAL. THE DIFFICULTY REQUIRES THAT ONLY THE REPORTED PRODUCT WAS REMOVED. THERE WAS EXCESSIVE TORQUE USED DURING ADVANCEMENT OR DELIVERY OF THE DEVICE. WHEN THE FIRST RESISTANCE WAS PERCEIVED, THE SURGEON PERSISTED. AN EXTRA +- 5CM WAS ACHIEVED, BEFORE BLOCKING COMPLETELY

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10378818 ↗

Other Catheter, angioplasty, peripheral, transluminal devices

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