Savvy Long PTA Dilatation Catheter 436-2022LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741132742), received between Apr 16, 2019 and Jul 11, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 436-2022L PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED A BREAK AND DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8783147 ↗
• InjuryApr 16, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  POST DILATION, IT WAS DIFFICULT TO REMOVE THE SAVVY LONG BALLOON CATHETER VIA THE SHEATH AS IT BECAME ELONGATED AND DETACHED FROM THE CATHETER. THERE WAS NO PATIENT INJURY. THE DEVICE WAS REMOVED FROM THE PATIENT WITH USE OF A GOOSE NECK SNARE. THE TARGET LESION IS THE ANTERIOR TIBIAL ARTERY WHICH WAS MODERATELY CALCIFIED WITH A COMBINATION OF STENOSES AND OCCLUSIONS, APPROX 20 CM IN LENGTH. THE DEVICE WAS PREP ACCORDING TO THE INSTRUCTION FOR USE WITH NO DEFECTS NOTED DURING PREP. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED THROUGH THE BALLOON DURING PREP. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. A COMPETITOR'S CONTRAST MEDIA AND INFLATION DEVICE WAS USED WITH A RATION OF SIXTY/FORTY. THE INFLATION DEVICE WAS SUCCESSFULLY USED WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THE CATHETER HAS NEVER BEEN IN AN ACUTE BEND. A 4FR BRITE TIP SHEATH WAS USED AND THEN UPSIZED TO 6FR BRITE TIP SHEATH. THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8520326 ↗