Savvy Long PTA Dilatation Catheter 436-2012XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741132674), received between Jul 11, 2019 and Oct 8, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2021Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH THE FEMORAL POPLITEAL ARTERY, THE DEVICE ALLEGEDLY LEAKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12595660 ↗
• MalfunctionSep 20, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PREPARATION FOR ANGIOPLASTY PROCEDURE, THE TIP OF THE PTA BALLOON WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497505 ↗
• MalfunctionApr 13, 2020Material Rupture; Detachment of Device or Device Component; Device-Device Incompatibility; Material Rupture; Detachment of Device or Device Component; Device-Device Incompatibility

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 436-2012X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE, DEVICE-DEVICE INCOMPATIBILITY, DETACHMENT OF DEVICE OR DEVICE COMPONENT, BREAK, RETRACTION PROBLEM AND MATERIAL SEPARATION. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT IS (B)(6) YEARS OF AGE, THE GENDER IS MALE, AND THE WEIGHT IS (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9955555 ↗
• MalfunctionJul 11, 2019Material Rupture; Material Deformation; Material Rupture; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 436-2012X. PTA DILATATION CATHETER ALLEGEDLY HAD A PINHOLE RUPTURE AT 12ATM. IT WAS FURTHER REPORTED THAT ANOTHER DILATATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT IS (B)(6) OF AGE, THE GENDER IS MALE, AND THE WEIGHT IS (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8783288 ↗