Sleek PTA Dilatation Catheter 425-2506XRecalls & reported problems
Clearstream Technologies Limited · Sleek PTA Dilatation Catheter 2.5mm 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 00801741132315), received between Feb 7, 2018 and Jan 13, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture2
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.
MalfunctionJan 13, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 425-2506X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE MATERIAL RUPTURE, ONE INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT INFORMATION WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9582940 ↗MalfunctionFeb 7, 2018Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PTA BALLOON ALLEGEDLY RUPTURED (TYPE OF RUPTURE UNKNOWN) DURING TREATMENT IN THE CALCIFIED POSTERIOR TIBIAL ARTERY. REPORTEDLY, THE DEVICE WAS REMOVED WITHOUT INCIDENT FROM THE PATIENT AND AN ALTERNATIVE BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7248666 ↗
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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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