Savvy Long PTA Dilatation Catheter 436-2522LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741132865), received between Feb 23, 2018 and Oct 16, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 16, 2019Material Rupture; Stretched; Detachment of Device or Device Component; Material Rupture; Stretched; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 436-2522L, PTA BALLOON DILATATION CATHETER, ALLEGEDLY BURST, STRETCHED, AND DETACHED. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9199599 ↗
• MalfunctionNov 13, 2018Break; Detachment of Device or Device Component; Packaging Problem; Break; Detachment of Device or Device Component; Packaging Problem

  IT WAS REPORTED THAT DURING PREPARATION, A BREAK ON THE PTA BALLOON CATHETER WAS ALLEGEDLY IDENTIFIED. IT WAS FURTHER REPORTED THAT THE PROTECTIVE SLEEVE ON THE BALLOON COULD NOT BE REMOVED WITHOUT FURTHER DAMAGE TO THE BALLOON. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8067168 ↗
• MalfunctionNov 13, 2018Break; Detachment of Device or Device Component; Packaging Problem; Break; Detachment of Device or Device Component; Packaging Problem

  IT WAS REPORTED THAT DURING PREPARATION, A BREAK ON THE PTA BALLOON CATHETER WAS ALLEGEDLY IDENTIFIED. IT WAS FURTHER REPORTED THAT THE PROTECTIVE SLEEVE ON THE BALLOON COULD NOT BE REMOVED WITHOUT FURTHER DAMAGE TO THE BALLOON. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8067036 ↗
• MalfunctionFeb 23, 2018Break; Device Damaged Prior to Use; Detachment of Device or Device Component; Break; Device Damaged Prior to Use; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PREPARATION FOR PROCEDURE THE HEALTH CARE PROVIDER IDENTIFIED THE PTA BALLOON WAS ALLEGEDLY SEPARATED, NOT ON THE SHAFT, AND THE DEVICE WAS ALLEGEDLY BROKEN. REPORTEDLY, ANOTHER PTA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7293101 ↗