Athletis™ H74939347080470Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08714729974055), received between Oct 12, 2021 and Apr 2, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT FOREARM VEIN. AN 8.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE FIRST INFLATION AT 24 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED FROM A PINHOLE. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769529 ↗
• MalfunctionFeb 19, 2026Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26JAN2026. THE RETURNED DEVICE EVALUATION REVEALED A BALLOON PINHOLE. IT WAS REPORTED THAT RECAPTURE FAILURE OCCURRED. AN 8.0MM X 40MM X 75CM ATHLETIS WAS SELECTED FOR USE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24391885 ↗
• MalfunctionFeb 4, 2026Nonstandard Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09JAN2026. IT WAS REPORTED THAT BALLOON RECAPTURE WAS NOT POSSIBLE. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERIOVENOUS FISTULA. AN 8.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RECAPTURE WAS NOT POSSIBLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A PINHOLE IN THE BALLOON MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261596 ↗
• MalfunctionNov 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED COMMON FEMORAL ARTERY. AN 8.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 8 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584864 ↗
• MalfunctionNov 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE 90% TO 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED, NON-TORTUOUS ARTERIOVENOUS (AV) FISTULA. A 8.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 20 ATMOSPHERES FOR FIVE SECONDS. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510869 ↗
• MalfunctionAug 4, 2025Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10JUL2025. IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO CROSS THE SHEATH. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED BRACHIOCEPHALIC VEIN. A 8.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE 6F NON-BOSTON SCIENTIFIC SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A PINHOLE LEAK WAS NOTED 4MM DISTAL OF THE DISTAL MARKERBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22704301 ↗
• MalfunctionJun 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED VESSEL IN THE UPPER ARM VEIN. A 8.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT 22 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22332264 ↗
• MalfunctionJun 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RADIOCEPHALIC ARTERIOVENOUS FISTULA (AVF). AN 8.0MM X 40MM X 75CM ATHLETES BALLOON CATHETER WAS SELECTED FOR USE. DURING INFLATION, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144926 ↗
• MalfunctionApr 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE BRACHIAL CEPHALIC VEIN. AN 8.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING 7TH INFLATION AT 30 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED IN A PINHOLE FORM AT AROUND THE CENTER. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 90% STENOSED, MILDLY TORTUOUS AND SEVERELY CALCIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21853506 ↗
• MalfunctionDec 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON FEMORAL ARTERY. AN 8.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857235 ↗
• MalfunctionNov 26, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY WAS ENCOUNTERED.USING A 7FR INTRODUCER, AN 8.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON CATHETER BECAME ENTRAPPED IN THE TROCHLEAR VESSEL DURING SECONDARY ENTRY. ANOTHER OF SAME PRODUCT WAS USED ON THE PATIENT WITHOUT INCIDENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20783302 ↗
• MalfunctionOct 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED VESSEL IN THE UPPER ARM. AN 8.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE MIDDLE PART OF THE BALLOON RUPTURED UPON SECOND INFLATION AT 24 ATMOSPHERES FOR 10 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509675 ↗
• MalfunctionOct 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED NEAR THE LEFT VENOUS ANASTOMOSIS. AN 8.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FOURTH INFLATION AT 2 ATMOSPHERES. THE EXACT PRESSURE AT EACH INFLATION IS UNKNOWN, BUT THE PRESSURE WAS GRADUALLY INCREASED STARTING FROM 4 ATMOSPHERES, WITH A MAXIMUM OF 20 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20445759 ↗
• MalfunctionMay 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON FEMORAL ARTERY. A 1 8.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 20 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19361597 ↗
• MalfunctionNov 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 8.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON EXPLODED UPON INFLATION AT 26 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18175821 ↗
• MalfunctionNov 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED BRACHIAL VEIN. A 8.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED; HOWEVER, DURING THE 6TH INFLATION AT 30 ATMOSPHERES FOR 30 SECONDS, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088150 ↗
• MalfunctionOct 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 8.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS INFLATED AT 20-25 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965872 ↗
• MalfunctionOct 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 8.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS SELECTED FOR USE IN THE FISTULA PROCEDURE. HOWEVER, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17951670 ↗
• MalfunctionJun 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUBCLAVIAN VEIN. A 7.0MM X 40MM X 75CM AND AN 8.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETERS WERE EACH ADVANCED AND INFLATED TO 30 ATMOSPHERES FOR 30 SECONDS. HOWEVER, THE 7.0MM X 40MM X 75CM BALLOON RUPTURED ON THE FIFTH INFLATION AND THE 8.0MM X 40MM X 75CM BALLOON RUPTURED ON THE INITIAL INFLATION. THE BALLOONS WERE REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17206281 ↗
• MalfunctionMay 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED FISTULA. TWO 8.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETERS WERE ADVANCED FOR DILATION. HOWEVER, THE FIRST BALLOON RUPTURED WHEN IT WAS INFLATED AT 24 ATMOSPHERES (ATM), AND THE SECOND BALLOON ALSO BURST WHEN INFLATED AT 26ATM. THE PHYSICIAN BELIEVED THAT THERE MAY HAVE BEEN A BALLOON PERFORATION AFTER INFLATING WITH THESE BALLOONS AS THERE WAS CONTRAST LEAKING AFTER ANGIOGRAPHY. BOTH DEVICES WERE REMOVED AND THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 10MM NON-BOSTON SCIENTIFIC BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17031922 ↗
• MalfunctionMay 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED FISTULA. TWO 8.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETERS WERE ADVANCED FOR DILATION. HOWEVER, THE FIRST BALLOON RUPTURED WHEN IT WAS INFLATED AT 24 ATMOSPHERES (ATM), AND THE SECOND BALLOON ALSO BURST WHEN INFLATED AT 26ATM. THE PHYSICIAN BELIEVED THAT THERE MAY HAVE BEEN A BALLOON PERFORATION AFTER INFLATING WITH THESE BALLOONS AS THERE WAS CONTRAST LEAKING AFTER ANGIOGRAPHY. BOTH DEVICES WERE REMOVED AND THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 10MM NON-BOSTON SCIENTIFIC BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17031852 ↗
• MalfunctionMar 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. AN 8.0MM X 40MM X 75CM ATHLETIS PTA BALLOON CATHETER WAS ADVANCED FOR DILATATION OF THE TARGET LESION LOCATED IN A FISTULA. HOWEVER, THE BALLOON RUPTURED DURING INFLATION AT 22 ATMOSPHERES. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16515492 ↗
• InjuryDec 21, 2022Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE. THE PATIENT PRESENTED WITH SLOW FLOW AND UNDERWENT ARTERIOVENOUS FISTULAGRAM. AN 8.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS USED. HOWEVER, DURING THE PROCEDURE, THE BALLOON WOULD NOT DEFLATE. THE PHYSICIAN TRIED USING TWO DIFFERENT NON-BOSTON SCIENTIFIC SYRINGES AND ENDED UP USING A 21G NEEDLE TO POP THE BALLOON. THE PHYSICIAN PIERCED THE BALLOON THROUGH THE SKIN AND WAS ABLE TO PULL IT THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16026865 ↗
• MalfunctionOct 12, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE HAD OCCURRED. A DILATION WAS BEING PERFORMED ON A 90% STENOSED, MODERATELY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE COMMON ILIAC ARTERY. THE 8.0 MM X 40MM ATHLETIS BALLOON RUPTURED ON THE THIRD INFLATION AT EIGHT ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12620622 ↗