Sleek PTA Dilatation Catheter 425-3015XRecalls & reported problems
Clearstream Technologies Limited · Sleek PTA Dilatation Catheter 3.0mm x 150mm balloon, 155cm shaft · Class 2
All models of Sleek PTA Dilatation Catheter (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741132469), received between Dec 30, 2021 and Dec 30, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Entrapment of Device” (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
- Entrapment of Device1
- Material Separation1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 30, 2021Entrapment of Device; Material Separation; Entrapment of Device; Material Separation
IT WAS REPORTED THAT DURING A PERIPHERAL PROCEDURE IN WHICH THE TARGET VESSEL WAS THE SUPERFICIAL FEMORAL ARTERY (SFA) THE BALLOON CATHETER OF THE DEVICE WAS ALLEGEDLY NOTED TO BE CAUGHT ON TO A STENT. IT WAS FURTHER REPORTED THAT THE DISTAL TIP OF THE CATHETER GOT SEPARATED FROM THE BODY OF THE DEVICE. ANOTHER STENT WAS DEPLOYED TO HOLD THE SEPARATED SECTIONS OF THE DEVICE. THE PATIENT WAS REPORTED TO BE IN A STABLE CONDITION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13115850 ↗
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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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