Sleek OTW PTA Dilatation Catheter 426-1504XRecalls & reported problems
Clearstream Technologies Limited · Sleek OTW PTA Dilatation Catheter 1.5mm x 40mm balloon, 150cm shaft · Class 2
All models of Sleek OTW PTA Dilatation Catheter (24)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741133527), received between Mar 22, 2018 and Sep 11, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (3 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 Rupture3
- Deflation Problem1
- Inflation Problem1
- Material Deformation1
- Stretched1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2023Deflation Problem; Inflation Problem; Material Rupture; Material Deformation; Deflation Problem; Inflation Problem; Material Rupture; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON CATHETER ALLEGEDLY HAD INFLATION ISSUE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17717736 ↗MalfunctionJul 16, 2020Material Rupture; Stretched; Material Rupture; Stretched
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 426-1504X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND CATHETER STRETCHED. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE PATIENT AGE WEIGHT AND GENDER WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10283222 ↗MalfunctionMar 22, 2018Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PTA BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7364421 ↗
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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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