Sleek PTA Dilatation Catheter 425-2015XRecalls & reported problems
Clearstream Technologies Limited · Sleek PTA Dilatation Catheter 2.0mm x 150mm balloon, 155cm 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741132278), received between Feb 9, 2018 and Apr 19, 2019 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (4 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 Advance4
- Material Deformation4
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 19, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL 425-2015X PTA CATHETER ALLEGEDLY FAILED TO CROSS THE LESION IN THE ANTERIOR TIBIAL ARTERY. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT WHOSE AGE, WEIGHT AND GENDER WAS NOT PROVIDED. THIS PATIENT HAD NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8533004 ↗MalfunctionOct 30, 2018Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
IT WAS REPORTED THAT THE PTA BALLOON CATHETER ALLEGEDLY FAILED TO CROSS THE LESION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8021116 ↗MalfunctionSep 26, 2018Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
IT WAS REPORTED THAT THE PTA BALLOON DILATATION CATHETER ALLEGEDLY WOULD NOT CROSS THE LESION IN THE ANTERIOR TIBIAL ARTERY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7912196 ↗MalfunctionJun 15, 2018Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
IT WAS REPORTED THAT DURING TREATMENT OF A CTO BEHIND THE KNEE LESION WITH AN IPSILATERAL APPROACH, THE PTA BALLOON CATHETER ALLEGEDLY WOULD NOT CROSS THE LESION. REPORTEDLY, ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7606885 ↗MalfunctionFeb 9, 2018Material Rupture; Material Rupture
IT WAS REPORTED THAT THE BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7260268 ↗
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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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