Sleek OTW PTA Dilatation Catheter 426-2010XRecalls & reported problems
Clearstream Technologies Limited · Sleek OTW PTA Dilatation Catheter 2.0mm x 100mm 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
- 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 00801741133596), received between Jul 16, 2020 and Jul 16, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
- Component Missing1
- Detachment of Device or Device Component1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2020Break; Component Missing; Detachment of Device or Device Component; Break; Component Missing; Detachment of Device or Device Component
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 426-2010X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED COMPONENT MISSING, DETACHMENT AND BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ALLEGED FAILURE MODE HAD NO PATIENT INVOLVEMENT. AGE, WEIGHT, AND GENDER OF THE PATIENT WAS NOT PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 10283327 ↗
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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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