AngioSculpt OTW PTA Scoring Balloon CatheterRecalls & reported problems across all models
The Spectranetics Corporation · 15 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 176
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls
- 0
We found 15 models of AngioSculpt OTW PTA Scoring Balloon Catheter by The Spectranetics Corporation in the FDA's device registry (GUDID). Together they are named in 176 adverse event reports in the FDA's MAUDE database, received between Dec 23, 2015 and Sep 23, 2026 — classified as 14 injuries, 162 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (154 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 AngioSculpt OTW PTA Scoring Balloon Catheter problems
Device problems
- Material Rupture154
- Entrapment of Device12
- Improper or Incorrect Procedure or Method11
- Burst Container or Vessel4
- Deflation Problem4
- Detachment of Device or Device Component3
- Material Separation3
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions117
- No Consequences Or Impact To Patient50
- Atherosclerosis3
- Peripheral Vascular Disease2
- Thrombosis/Thrombus2
- Embolism/Embolus1
- Failure to Anastomose1
- Injury1
AngioSculpt OTW PTA Scoring Balloon Catheter models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AngioSculpt OTW PTA Scoring Balloon Catheter 2092-6040Catheter, Percutaneous, Cutting/Scoring41 reports
- AngioSculpt OTW PTA Scoring Balloon Catheter 2076-5040Catheter, Percutaneous, Cutting/Scoring31 reports
- AngioSculpt OTW PTA Scoring Balloon Catheter 2092-5040Catheter, Percutaneous, Cutting/Scoring28 reports
- AngioSculpt OTW PTA Scoring Balloon Catheter 2076-6040Catheter, Percutaneous, Cutting/Scoring17 reports
- AngioSculpt OTW PTA Scoring Balloon Catheter 2105-6040Catheter, Percutaneous, Cutting/Scoring17 reports
- AngioSculpt OTW PTA Scoring Balloon Catheter 2092-4040Catheter, Percutaneous, Cutting/Scoring13 reports
- AngioSculpt OTW PTA Scoring Balloon Catheter 2076-4040Catheter, Percutaneous, Cutting/Scoring6 reports
- AngioSculpt OTW PTA Scoring Balloon Catheter 2334-7040Catheter, Percutaneous, Cutting/Scoring5 reports
- AngioSculpt OTW PTA Scoring Balloon Catheter 2076-5020Catheter, Percutaneous, Cutting/Scoring4 reports
- AngioSculpt OTW PTA Scoring Balloon Catheter 2332-8040Catheter, Percutaneous, Cutting/Scoring4 reports
- AngioSculpt OTW PTA Scoring Balloon Catheter 2155-3040Catheter, Percutaneous, Cutting/Scoring3 reports
- AngioSculpt OTW PTA Scoring Balloon Catheter 2334-8040Catheter, Percutaneous, Cutting/Scoring3 reports
- AngioSculpt OTW PTA Scoring Balloon Catheter 2076-4020Catheter, Percutaneous, Cutting/Scoring2 reports
- AngioSculpt OTW PTA Scoring Balloon Catheter 2076-6020Catheter, Percutaneous, Cutting/Scoring1 report
- AngioSculpt OTW PTA Scoring Balloon Catheter 2332-7040Catheter, Percutaneous, Cutting/Scoring1 report
Recent AngioSculpt OTW PTA Scoring Balloon Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Material Rupture; Material Separation
An AngioSculpt catheter was used for a peripheral therapeutic procedure in a moderately tortuous AV shunt. During use, at initial inflation, the balloon ruptured at 14 atm (RBP). When the catheter was being removed, resistance was encountered, and the balloon with the distal tip separated within the patient (photo provided). The remaining portion of the catheter, including the scoring element, was removed from the patient. The retained balloon was subsequently retrieved with a snare, and angiogram confirmed nothing was left in the patient. The procedure was completed with no patient injury reported.This Adverse Event and Product Problem is being submitted for balloon rupture and separation; requiring intervention.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870253 ↗MalfunctionSep 18, 2026Entrapment of Device; Material Rupture
An AngioSculpt catheter was used for a therapeutic peripheral procedure in the SFA. During inflation, the balloon immediately burst below RBP (RBP:14 atm) (device evaluated; no leak observed). A second AngioSculpt was used; however, the balloon popped instantly upon inflation (RBP:12 atm). The AngioSculpt and concomitant devices were removed all together. The procedure was completed with a non-AngioSculpt. No patient injury reported.This Product Problem is being submitted for the second AngioSculpt for balloon rupture and removal as a system; potential for harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821269 ↗MalfunctionSep 16, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791917 ↗MalfunctionJul 1, 2026Entrapment of Device
THE ANGIOSCULPT CATHETER WAS USED FOR A PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED MID SFA. DURING USE, THE ANGIOSCULPT BECAME STUCK AT THE LESION SITE AND COULD NOT BE REMOVED. THEREFORE, IT WAS SUBSEQUENTLY WITHDRAWN TOGETHER WITH THE GUIDEWIRE, ALLOWING SUCCESSFUL REMOVAL OF THE SYSTEM. THE PROCEDURE WAS COMPLETED WITH A NEW CATHETER WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO REMOVAL AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25684175 ↗MalfunctionJul 1, 2026Material Rupture
AN ANGIOSCULPT DEVICE WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING THE SECOND INFLATION AT 8 ATM (RBP: 14 ATM), THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25681007 ↗MalfunctionJun 15, 2026Material Rupture
AN ANGIOSCULPT DEVICE WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING THE FIRST INFLATION AT NOMINAL PRESSURE (NOMINAL: 8 ATM, RBP: 14 ATM), THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NEW EQUIVALENT PRODUCT. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25511573 ↗MalfunctionMay 20, 2026Material Rupture
AN ANGIOSCULPT DEVICE WAS USED FOR A PERIPHERAL THERAPEUTIC PROCEDURE. DURING FIRST INFLATION AT 2 ATM (RBP: 14 ATM), THE BALLOON FAILED TO EXPAND. WHEN WATER WAS FLUSHED THROUGH THE BALLOON, A PINHOLE WAS IDENTIFIED. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25236397 ↗MalfunctionMay 13, 2026Material Rupture
AN ANGIOSCULPT DEVICE WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING THE FIRST INFLATION AT 4 ATM (RBP: 14 ATM), THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25165313 ↗MalfunctionApr 21, 2026Material Separation
AN ANGIOSCULPT CATHETER WAS USED FOR A PERIPHERAL ARTERIOVENOUS (AV) SHUNT PROCEDURE. DURING ADVANCEMENT, THE BALLOON COULD NOT CROSS THROUGH THE ANASTOMOSIS SITE. WHEN ATTEMPTING TO WITHDRAW THE UNINFLATED BALLOON FROM THE SHEATH, IT BECAME STUCK INSIDE AND COULD NOT BE RETRIEVED. STRONG TRACTION WAS APPLIED TO THE SHAFT BUT THE SCORING ELEMENT SEPARATED; REMOVING THE SHEATH AND CATHETER TOGETHER. THE SEPARATED SCORING ELEMENT WAS ABLE TO BE REMOVED SINCE IT WAS PROTRUDING THROUGH THE SKIN, KEEPING THE GUIDEWIRE IN PLACE. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. ALTHOUGH THE COMPLAINT DETAILS STATE THE BALLOON WAS UNINFLATED, A PHOTO PROVIDED BY THE CUSTOMER SHOWS AN INFLATED BALLOON. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO SCORING ELEMENT SEPARATION; POTENTIAL FOR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24945014 ↗MalfunctionApr 9, 2026Material Rupture
AN ANGIOSCULPT DEVICE WAS USED FOR A PERIPHERAL THERAPEUTIC PROCEDURE IN THE AV SHUNT. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 12 ATM (RBP: 14 ATM). THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832739 ↗MalfunctionMar 20, 2026Material Rupture
AN ANGIOSCULPT DEVICE WAS USED FOR A PERIPHERAL THERAPEUTIC PROCEDURE IN THE SFA. DURING USE, THE BALLOON RUPTURED UNDER NOMINAL PRESSURE (NOMINAL: 8 ATM, RBP: 14 ATM). THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON CATHETER. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24656280 ↗MalfunctionFeb 24, 2026Material Rupture
AN ANGIOSCULPT DEVICE WAS USED FOR A PERIPHERAL THERAPEUTIC PROCEDURE IN A MODERATELY CALCIFIED MID SFA. DURING INFLATION, THE BALLOON RUPTURED AT 6 ATM (RBP: 12 ATM). THE PROCEDURE WAS COMPLETED WITH A REGULAR BALLOON. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24433297 ↗MalfunctionFeb 6, 2026Material Rupture
AN ANGIOSCULPT CATHETER WAS USED FOR A THERAPEUTIC PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED MID SFA. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 12 ATM (RBP: 14 ATM). THE PROCEDURE WAS COMPLETED WITH A NEW CATHETER. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24283860 ↗MalfunctionFeb 5, 2026Material Rupture
AN ANGIOSCULPT DEVICE WAS USED FOR A PERIPHERAL AV SHUNT PROCEDURE IN THE RADIAL ARTERY. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 6 ATM (RBP: 14 ATM). THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24272697 ↗MalfunctionFeb 5, 2026Material Rupture
THE ANGIOSCULPT DEVICE WAS USED FOR A PERIPHERAL PROCEDURE IN THE DISTAL CEPHALIC VEIN. DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT NOMINAL PRESSURE (8 ATM). THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. DURING THE RETURNED PRODUCT EVALUATION, VISUAL INSPECTION CONFIRMED A BALLOON RADIAL BURST. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE BALLOON RADIAL BURST THAT CAN RESULT IN A POTENTIAL FOR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24272036 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page