Savvy Long PTA Dilatation Catheter 436-2015XRecalls & reported problems
Clearstream Technologies Limited · Savvy Long PTA Dilatation Catheter 2.0mm x 150mm balloon, 150cm shaft · Class 2
All models of Savvy Long PTA Dilatation Catheter (19)
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 00801741132704), received between Oct 18, 2019 and Apr 16, 2020 — 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.
Most reported problems
Device problems
- Material Rupture2
- Complete Blockage1
- Inflation Problem1
- Retraction 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.
MalfunctionApr 16, 2020Complete Blockage; Material Rupture; Complete Blockage; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 436-2015X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9968824 ↗MalfunctionOct 18, 2019Inflation Problem; Retraction Problem; Material Rupture; Inflation Problem; Retraction Problem; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 436-2015X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED INFLATION ISSUE, MATERIAL RUPTURE, AND RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID INVOLVE A PATIENT WITH NO PATIENT INJURY. THE PATIENT WAS A (B)(6) FEMALE THAT WEIGHED (B)(6).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9211429 ↗
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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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