Sleek OTW PTA Dilatation Catheter 426-1512XRecalls & reported problems
Clearstream Technologies Limited · Sleek OTW PTA Dilatation Catheter 1.5mm x 120mm 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
- 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 00801741133558), received between Feb 17, 2022 and Sep 8, 2022 — 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
- Stretched2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2022Material Rupture; Stretched; Material Rupture; Stretched
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH POPLITEAL ARTERY, THE BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15376451 ↗MalfunctionFeb 17, 2022Material Rupture; Stretched; Material Rupture; Stretched
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH THE PERONEAL ARTERY THROUGH SEVERE CALCIFICATION, THE BALLOON ALLEGEDLY RUPTURED AT 14 ATM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13547422 ↗
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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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