Sleek OTW PTA Dilatation Catheter 426-5028XRecalls & reported problems
Clearstream Technologies Limited · Sleek OTW PTA Dilatation Catheter 5.0mm x 280mm 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 00801741134036), received between May 27, 2021 and Dec 27, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Material Rupture2
- Detachment of Device or Device Component1
- Improper or Incorrect Procedure or Method1
- Inflation Problem1
- Material Twisted/Bent1
- Retraction Problem1
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.
MalfunctionDec 27, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY GOT CAUGHT ON CALCIUM AND POPPED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21025717 ↗MalfunctionMay 27, 2021Inflation Problem; Retraction Problem; Material Rupture; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Material Twisted/Bent; Inflation Problem; Retraction Problem; Material Rupture; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE BALLOON ALLEGEDLY TWISTED. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED DURING THE PROCEDURE. REPORTEDLY THE DEVICE ALSO HAD A RETRACTION ISSUE AND THE BALLOON WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11893012 ↗
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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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