Savvy Long PTA Dilatation Catheter 436-2512XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741132797), received between Apr 19, 2019 and Jul 16, 2020 — classified as 3 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 436-2512X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ALLEGED MALFUNCTION HAD PATIENT INVOLVEMENT HOWEVER THERE WERE NO PATIENT CONSEQUENCES. THE MALE PATIENT WAS REPORTED TO BE (B)(6) AND WEIGHED (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10283466 ↗
• MalfunctionJul 15, 2020Device Markings/Labelling Problem; Device Dislodged or Dislocated; Device Markings/Labelling Problem; Device Dislodged or Dislocated

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 436-2512X OTW PTA CATHETER ALLEGEDLY EXPERIENCED DEVICE DISLOCATION AND DEVICE MARKING PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE WEIGHT OF (B)(6) YEAR OLD MALE IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10280769 ↗
• MalfunctionApr 19, 2019Retraction Problem; Material Rupture; Material Deformation; Retraction Problem; Material Rupture; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 436-2512X SAVVY LONG OTW PTA CATHETER EXPERIENCED RETRACTION ISSUES AND MATERIAL RUPTURE. THE DEVICE WAS USED ON THE PATIENT WITH NO REPORTED INJURY. THE AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532944 ↗