Sleek OTW PTA Dilatation Catheter 426-4028XRecalls & reported problems
Clearstream Technologies Limited · Sleek OTW PTA Dilatation Catheter 4.0mm 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
- 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 00801741133954), received between Jul 27, 2023 and Jul 27, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Inflation Problem1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2023Inflation Problem; Difficult to Remove; Use of Device Problem; Inflation Problem; Difficult to Remove; Use of Device Problem
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON CATHETER WAS ALLEGEDLY FAILED TO UNWRAP AND INFLATE PROPERLY. IT WAS FURTHER REPORTED THAT THERE WAS SOME RESISTANCE WHEN REMOVING THE DEVICE. THE DEVICE WAS ABLE TO BE REMOVED IN ONE PIECE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17406779 ↗
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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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