Athletis™ H74939347070470Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08714729973911), received between Sep 13, 2021 and Aug 11, 2026 — classified as 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Material Rupture

  It was reported that a balloon rupture occurred.The target lesion was located in the cephalic vein of the forearm. A 7.0 mm x 40 mm x 75 cm Athletis balloon catheter was advanced to the lesion site for dilatation. After the balloon was positioned, inflation was initiated. When the inflation pressure reached 26 atmospheres, further pressure increase was not possible. The balloon catheter was withdrawn and upon reinflation, the balloon was observed to have ruptured. The device was removed and the procedure was completed with another of same device. No patient injury was reported as a result of this event. The patient condition following procedure was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201430 ↗
• MalfunctionFeb 23, 2026Fluid/Blood Leak; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT DEVICE FAILED TO INFLATE AND LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA (AVF). A 7.0MM X 40MM X 75CM ATHLETIS WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS A CONTRAST LEAKAGE AND THE BALLOON DID NOT EXPAND. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416517 ↗
• MalfunctionFeb 16, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 7.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION AT 20 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED IN A PINHOLE FORM, LOCATED NEAR THE SHOULDER ON THE DISTAL SIDE OF THE BALLOON. THE DEVICE WAS REMOVED, AND 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 24345654 ↗
• MalfunctionFeb 2, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VEIN NEAR THE ELBOW. A 7.0MM X 40MM X 75CM ATHLETICS BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT 34 ATMOSPHERES FOR 60 SECONDS, THE BALLOON RUPTURED. 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, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234480 ↗
• MalfunctionDec 21, 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 THE BALLOON BECAME STUCK WITH THE GUIDEWIRE. A 7.0 MM X 40 MM X 75 CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION OF AN AVF STENOSIS. DURING POSITIONING, THE BALLOON BECAME STUCK ON THE GUIDEWIRE AND COULD NOT BE ADVANCED INTO THE LESION. AFTER SEVERAL ATTEMPTS, THE DEVICE WAS DETERMINED TO BE DEFECTIVE. IT WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861070 ↗
• MalfunctionSep 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL VEIN OF THE FOREARM. A 7.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED WHILE BEING INFLATED TO 32 ATMOSPHERES. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF TIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE TWO DEVICES USED IN THE SAME ONE PROCEDURE. IT WAS FURTHER REPORTED THAT THE PATIENT DID NOT HAVE SIGNIFICANTLY CHALLENGING ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22971176 ↗
• MalfunctionSep 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 72% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED CEPHALICA ANTEBRACHII. A 7.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE SECOND INFLATION WHILE BEING INFLATED TO 32 ATMOSPHERES FOR 30 SECONDS. THE PROCEDURE WAS COMPLETED USING 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 22967531 ↗
• MalfunctionJun 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ARTERIOVENOUS FISTULA ON THE UPPER ARM. A 7.0MM X 40MM X 75CM ATHLETIS BALLOON WAS ADVANCED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. HOWEVER, THE BALLOON BURST DURING INITIAL INFLATION AT RATED BURST PRESSURE UNDER 30 SECONDS. 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 22307850 ↗
• MalfunctionJun 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS BURST. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158392 ↗
• MalfunctionApr 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CEPHALIC VEIN. A 7.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FOURTH INFLATION AT 14 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. 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 21936265 ↗
• MalfunctionFeb 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND SEVERELY CALCIFIED COMMON FEMORAL ARTERY. A 7.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION UNTIL IT REACHED TO 8 ATMOSPHERES. 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 21440144 ↗
• MalfunctionJan 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERIOVENOUS FISTULA. A 7.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST WHILE BLOWING IT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS STABLE. IT WAS FURTHER REPORTED THAT THE STENOSED TARGET LESION WAS 75% AND WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. THE BALLOON BURST DURING SECOND INFLATION AT 16 TO 20 ATMOSPHERES UNDER 30 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21171974 ↗
• MalfunctionJul 22, 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 VESSEL. A 7.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 30 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19799755 ↗
• MalfunctionMay 22, 2024Leak/Splash; Leak/Splash

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT BALLOON LEAKAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 7.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS USED FOR DILATATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE CONTRAST MEDIUM HAD LEAKED OUT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373039 ↗
• MalfunctionMay 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT CENTRAL VEIN. A 7.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT 18 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19344137 ↗
• MalfunctionDec 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RADIAL ARTERIOVENOUS FISTULA. A 7.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED. HOWEVER, DURING INFLATION, THE BALLOON BURST. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18250185 ↗
• MalfunctionNov 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL IN THE LEFT FOREARM. A 7.0MM 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. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140351 ↗
• MalfunctionOct 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERIOVENOUS FISTULAS. A 7.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED WHILE BLOWING IT INSIDE THE PATIENTS BODY. THE DEVICE WAS REMOVED BY JUST SIMPLY PULLING OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967243 ↗
• MalfunctionOct 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS USED FOR THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. HOWEVER, DURING INFLATION, THE BALLOON BURST AT 30 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS TREATED WITHOUT ANY ABNORMALITIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17962527 ↗
• MalfunctionJul 6, 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 17269985 ↗
• MalfunctionFeb 6, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS PRESENT ON THE DEVICE. A 7.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS BROUGHT TO BIOHAZARD ROOM FOR ANALYSIS AS FOREIGN MATTER WAS OBSERVED PRESENT WITH THE DEVICE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16303387 ↗
• MalfunctionDec 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 7.0MM X 40MM X 75CM ATHLETIS BALLOON WAS SELECTED FOR A PROCEDURE IN THE BRACHIAL VEIN. PATIENT ANATOMY CONDITIONS REVEALED MODERATE TORTUOSITY, 99% STENOSIS AND MILD CALCIFICATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED ONCE TO 30 ATMOSPHERES (ATMS) FOR 10 SECONDS. DURING THIS INFLATION THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT PROBLEM USING THE NORMAL METHOD. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12940588 ↗
• MalfunctionSep 13, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE HAD OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED ON A 90% STENOSED, SEVERELY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE SUBCLAVIAN VEIN. THE 7.0MM X 40MM X 75CM ATHLETIS PTA BALLOON RUPTURED ON THE FIRST INFLATION AT 30 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITHOUT ISSUE OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460919 ↗