Sleek PTA Dilatation Catheter 425-3006XRecalls & reported problems
Clearstream Technologies Limited · Sleek PTA Dilatation Catheter 3.0mm x 60mm balloon, 150cm shaft · Class 2
All models of Sleek PTA Dilatation Catheter (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741132421), received between Oct 23, 2018 and Jul 23, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (2 reports).
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
- Failure to Advance2
- Material Deformation2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 23, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
THIS REPORT SUMMARIZES ONE MALFUNCTION . A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 425-3006X SLEEK RX PTA CATHETER ALLEGEDLY FAILED TO CROSS THE LESION IN A CALCIFIED AND OCCLUDED ANTERIOR TIBIAL ARTERY. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO REPORTED PATIENT INJURY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE PATIENTS AGE, WEIGHT, AND GENDER WERE NOT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8817251 ↗MalfunctionOct 23, 2018Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
IT WAS REPORTED THAT THE PTA BALLOON CATHETER ALLEGEDLY FAILED TO CROSS A TORTUOUS AND CALCIFIED SFA VESSEL WITH EIGHTY PERCENT STENOSIS. REPORTEDLY, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7997490 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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