Athletis™ H74939347050470Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729973676), received between Dec 28, 2022 and Mar 3, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DISSECTION OF TYPE C WAS NOTED. THE SUBJECT WAS ENROLLED INTO CLINICAL STUDY ON (B)(6) 2025, AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. DURING THE INDEX PROCEDURE, ANTI-COAGULATION THERAPY WAS ADMINISTERED. THE TARGET LESION WAS LOCATED IN THE LEFT ARM SWING POINT WITH 4.40 MM REFERENCE VESSEL DIAMETER, 52.23 MM LENGTH AND 61% STENOSIS WITH NO CALCIFICATION. PRE-DILATATION WAS PERFORMED USING 5 MM X 40 MM BOSTON SCIENTIFIC ATHLETIS BALLOON WITH RESIDUAL STENOSIS OF 25%. THE TARGET LESION WAS TREATED WITH 5 MM X 80 MM RANGER DRUG COATED BALLOON, STUDY DEVICE. POST PROCEDURE, THE RESIDUAL STENOSIS WAS 25%. INDEX CORE LAB ANGIOGRAPHY FINDINGS DATED (B)(6) 2025 REVEALED THAT THE TARGET LESION WAS LOCATED IN THE ANASTOMOSIS AND SWING POINT, WITH 4.3 MM REFERENCE VESSEL DIAMETER, 39.76 MM LENGTH, AND 62.79% DIAMETER STENOSIS. DISSECTION OF TYPE C WAS NOTED AFTER PRE-DILATATION USING 5 MM X 40 MM BOSTON SCIENTIFIC ATHLETIS BALLOON. POST TEST DEVICE USAGE (RANGER DRUG COATED BALLOON), THE DIAMETER STENOSIS WAS NOTED TO BE 4.76% WITH DISSECTION OF TYPE C UNCHANGED. THERE WAS MINIMAL RESIDUAL DISSECTION ON FINAL. OF NOTE, AS PER SITE INDEX PROCEDURE FORM NO D

  Patient problems: Vascular Dissection

  MAUDE report 24500147 ↗
• MalfunctionNov 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ANTECUBITAL VEIN. A 5.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING PROCEDURE, THE BALLOON BURST AT 30 ATMOSPHERES UPON REACHING THE LESION SITE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 70% STENOSED, MODERATELY TORTUOUS AND MILDLY CALCIFIED. THE BALLOON RUPTURED DURING THE FIRST INFLATION FOR 35 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510875 ↗
• MalfunctionNov 7, 2025Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CATHETER ENTRAPMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED RADIO CEPHALIC AARTERIOVENOUS FISTULA (AVF). A 5.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER BECAME STUCK WITH A NON-BOSTON SCIENTIFIC (NON-BSC) GUIDEWIRE AND DOES NOT MOVE. THE GUIDE WIRE AND BALLOON WERE REMOVED SIMULTANEOUSLY WITHOUT ANY ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENT RECOVERED WITHOUT ANY ILL EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497792 ↗
• MalfunctionSep 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 5.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON COULD NOT BE INFLATED DIRECTLY DURING EXPANSION AND EVENTUALLY, IT BURST. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062849 ↗
• MalfunctionOct 24, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS SHUNT VESSEL. A 5.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON DID NOT EXPAND AT ALL. THE PRESSURE WAS REDUCED TO 2 ATMOSPHERES, BUT THE BLOOD STARTED TO FLOW BACK WHEN THE BALLOON WAS BARELY EXPANDING. IT WAS SUSPECTED THAT THERE MIGHT BE A CONGESTION BETWEEN THE GUIDEWIRE LUMEN AND THE INFLATION LUMEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20529676 ↗
• MalfunctionJul 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT FISTULAPLASTY PROCEDURE. THE STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS AND MILDLY CALCIFIED LEFT ARTERIOVENOUS BEND FISTULA. A 5.0MM X 40MM X 75CM ATHLETIS PTA BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 34 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17385497 ↗
• MalfunctionDec 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE 90% STENOSED TARGET LESION WAS LOCATED IN AN INTERNAL SHUNT ANASTOMOSIS IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 5.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED. HOWEVER, DURING THE FIRST INFLATION AT 15 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT INJURIES REPORTED AND THE PATIENT CONDITION POST-PROCEDURE WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16064998 ↗