AthletisRecalls & reported problems across all models
Boston Scientific Corporation · 26 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 215
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 26 models of Athletis by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 215 adverse event reports in the FDA's MAUDE database, received between Mar 5, 2021 and Aug 17, 2026 — classified as 5 injuries, 210 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (178 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Athletis problems
Device problems
- Material Rupture178
- Adverse Event Without Identified Device or Use Problem14
- Leak/Splash11
- Inflation Problem10
- Entrapment of Device7
- Deflation Problem4
- Device-Device Incompatibility4
- Difficult to Advance3
Patient problems
- No Clinical Signs, Symptoms or Conditions211
- Vascular Dissection2
- Pain1
- Perforation of Vessels1
Athletis models
26 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Athletis™ H74939347080470Catheter, angioplasty, peripheral, transluminal24 reports
- Athletis™ H74939347070470Catheter, angioplasty, peripheral, transluminal23 reports
- Athletis™ H74939347120470Catheter, angioplasty, peripheral, transluminal20 reports
- Athletis™ H74939347061070Catheter, angioplasty, peripheral, transluminal17 reports
- Athletis™ H74939347100470Catheter, angioplasty, peripheral, transluminal16 reports
- Athletis™ H74939347060470Catheter, angioplasty, peripheral, transluminal14 reports
- Athletis™ H74939347060450Catheter, angioplasty, peripheral, transluminal13 reports
- Athletis™ H74939347051050Catheter, angioplasty, peripheral, transluminal12 reports
- Athletis™ H74939347061050Catheter, angioplasty, peripheral, transluminal11 reports
- Athletis™ H74939347050450Catheter, angioplasty, peripheral, transluminal10 reports
- Athletis™ H74939347080450Catheter, angioplasty, peripheral, transluminal10 reports
- Athletis™ H74939347051070Catheter, angioplasty, peripheral, transluminal9 reports
- Athletis™ H74939347050470Catheter, angioplasty, peripheral, transluminal7 reports
- Athletis™ H74939347080870Catheter, angioplasty, peripheral, transluminal5 reports
- Athletis™ H74939347050410Catheter, angioplasty, peripheral, transluminal3 reports
- Athletis™ H74939347081070Catheter, angioplasty, peripheral, transluminal3 reports
- Athletis™ H74939347090470Catheter, angioplasty, peripheral, transluminal3 reports
- Athletis™ H74939347100870Catheter, angioplasty, peripheral, transluminal3 reports
- Athletis™ H74939347060870Catheter, angioplasty, peripheral, transluminal2 reports
- Athletis™ H74939347071070Catheter, angioplasty, peripheral, transluminal2 reports
- Athletis™ H74939347080670Catheter, angioplasty, peripheral, transluminal2 reports
- Athletis™ H74939347090870Catheter, angioplasty, peripheral, transluminal2 reports
- Athletis™ H74939347060410Catheter, angioplasty, peripheral, transluminal1 report
- Athletis™ H74939347070450Catheter, angioplasty, peripheral, transluminal1 report
- Athletis™ H74939347080850Catheter, angioplasty, peripheral, transluminal1 report
- Athletis™ H74939347120670Catheter, angioplasty, peripheral, transluminal1 report
Recent Athletis adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50273301 ↗MalfunctionAug 13, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50244657 ↗MalfunctionAug 12, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50225927 ↗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 ↗MalfunctionJul 6, 2026Material Rupture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT FOREARM SHUNT VEIN SIDE. A 6.0MM X 40MM X 50CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 15 ATMOSPHERES FOR 10 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, 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 25728052 ↗MalfunctionJun 15, 2026Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL CEPHALIC VEIN OF THE FOREARM. A 5.0MM X 40MM X 50CM ATHLETIS BALLOON WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON RUPTURED DURING MULTIPLE INFLATIONS. THE DEVICE REMOVED WITHOUT ANY PROBLEM USING THE NORMAL METHOD, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 25511064 ↗MalfunctionApr 7, 2026Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED RADIAL ANTECUBITAL VEIN. A 6.0MM X 100MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE SECOND INFLATION AT 30 ATMOSPHERES FOR 1 MINUTE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24809090 ↗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 ↗MalfunctionMar 9, 2026Fluid/Blood Leak; Inflation Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11-FEB-2026. IT WAS REPORTED THAT BALLOON FAILED TO INFLATE AND A LEAK OCCURRED. A 0.0MM X 40MM X 75CM ATHLETIS BALLOON WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. THE TARGET LESION WAS LOCATED IN THE SUBCLAVIAN VEIN, AND WAS REPORTED TO BE 80% STENOSED WITH SEVERE TORTUOSITY AND MODERATE CALCIFICATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON DID NOT INFLATE. UPON WITHDRAWAL, A CONTRAST AGENT LEAK FROM THE BALLOON WAS OBSERVED. 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 BALLOON PINHOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24551848 ↗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 ↗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 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 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 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 ↗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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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