Sleek OTW PTA Dilatation Catheter 426-3010XRecalls & reported problems
Clearstream Technologies Limited · Sleek OTW PTA Dilatation Catheter 3.0mm 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
- 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 00801741133756), received between Feb 2, 2021 and May 24, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem1
- Difficult to Remove1
- Material Deformation1
- 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.
MalfunctionMay 24, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, THE BALLOON CATHETER ALLEGEDLY WOULD NOT DEFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY NOT POSSIBLE TO BE PULLED OUT OF THE UNKNOWN CATHETER SHEATH INTRODUCER. REPORTEDLY, THE BALLOON AND CATHETER SHEATH INTRODUCER WERE REMOVED TOGETHER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16990721 ↗MalfunctionFeb 2, 2021Retraction Problem; Material Deformation; Retraction Problem; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO RETRACT OVER THE WIRE AFTER DEFLATION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11264773 ↗
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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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