Sleek PTA Dilatation Catheter 425-2010XRecalls & reported problems
Clearstream Technologies Limited · Sleek PTA Dilatation Catheter 2.0mm x 100mm balloon, 150cm 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
- 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 00801741132254), received between Jun 1, 2018 and Jul 5, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Detachment of Device or Device Component1
- Inflation Problem1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 5, 2019Break
AS THE SURGEON WAS ADVANCING THE BALLOON CATHETER THROUGH THE SHEATH, THE CATHETER COMPLETELY BROKE. THE BALLOON CATHETER WAS REMOVED IN ITS ENTIRETY WITH NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8764021 ↗MalfunctionJun 1, 2018Inflation Problem; Detachment of Device or Device Component; Inflation Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A RIGHT LOWER EXTREMITY ARTERIOGRAM, THE BALLOON ALLEGEDLY FAILED TO INFLATE. AFTER MULTIPLE INFLATION ATTEMPTS, THE HUB WAS ALLEGEDLY LOOSE FROM THE CATHETER AND DISCONNECTED FROM THE CATHETER DURING REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7562526 ↗
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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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