Savvy Long PTA Dilatation Catheter 436-3015XRecalls & reported problems
Clearstream Technologies Limited · Savvy Long PTA Dilatation Catheter 3.0mm 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 00801741132940), received between Jul 11, 2019 and Mar 11, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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 Deformation2
- Break1
- Difficult to Advance1
- Material Rupture1
- Material Split, Cut or Torn1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2022Material Rupture; Difficult to Advance; Material Deformation; Material Split, Cut or Torn; Material Rupture; Difficult to Advance; Material Deformation; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LOWER EXTREMITY ARTERIOSCLEROSIS VIA A MODERATELY CALCIFIED LESION TO TREAT THE FEMORAL POPLITEAL SEGMENT AND THE SUPERFICIAL SEGMENT OF THE FEMUR, THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO REACH THE LESION AND IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED AT 12 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13730156 ↗MalfunctionJul 11, 2019Break; Retraction Problem; Material Deformation; Break; Retraction Problem; Material Deformation
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE EVENTS INDICATED THAT MODEL 436-3015X OTW PTA CATHETER EXPERIENCED A RETRACTION PROBLEM. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE DEVICE WAS USED IN THE PATIENT. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8783211 ↗
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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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