Catheter, Percutaneous, Cutting/scoring
Cardiovascular · 21 CFR 870.1250
To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material
Recent MDR events
2,083 adverse event reports on file
- AngioSculpt OTW PTA Scoring Balloon CatheterJul 31, 2026MalfunctionSpectranetics Corporation3005462046-2026-00053
- AngioSculpt OTW PTA Scoring Balloon CatheterJul 31, 2026MalfunctionSpectranetics Corporation3005462046-2026-00052
- AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross CoatingJul 30, 2026MalfunctionSpectranetics Corporation3005462046-2026-00051
- Aperta NSE PTA Balloon Dilatation CatheterJul 29, 2026MalfunctionNipro Vascular Corporation3007835716-2026-00095
- 2cm Peripheral Cutting BalloonJul 29, 2026MalfunctionBoston Scientific Corporation2124215-2026-40532
- 2cm Peripheral Cutting BalloonJul 29, 2026MalfunctionBoston Scientific Corporation2124215-2026-40227
- 2cm Peripheral Cutting BalloonJul 29, 2026MalfunctionBoston Scientific Corporation2124215-2026-40730
- 2cm Peripheral Cutting BalloonJul 29, 2026MalfunctionBoston Scientific Corporation2124215-2026-40733
- 2cm Peripheral Cutting BalloonJul 29, 2026MalfunctionBoston Scientific Corporation2124215-2026-40729
- 2cm Peripheral Cutting BalloonJul 29, 2026MalfunctionBoston Scientific Corporation2124215-2026-40735
Event type breakdown
Recalls
3 recall events for this product code
- Cook Inc.TerminatedJun 17, 2019
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248
Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, and balloon fragmentation in the patient.
Z-1756-2019 · View FDA record ↗ - Cook Inc.TerminatedJun 17, 2019
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252
Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, and balloon fragmentation in the patient.
Z-1757-2019 · View FDA record ↗ - Cook Inc.TerminatedJun 17, 2019
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35257
Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, and balloon fragmentation in the patient.
Z-1758-2019 · View FDA record ↗
Registered firms
71 firms currently registered for this product code
Sterigenics U.s., Llc
Salt Lake City, UT, US
Venturemed Group, Inc
Plymouth, MN, US
Synergy Health Ireland Ltd
Tullamore Offaly, IE
Transit Scientific, Llc
Salt Lake City, UT, US
C.r. Bard, Inc.
Queensbury, NY, US
C.r. Bard, Inc.
MADISON, GA, US
Synergy Health Sterilisation Uk Ltd
Daventry Northamptonshire, GB
Dk Medical Technology Co., Ltd.
Suzhou Jiangsu, CN
Sterigenics Us Llc
Los Angeles, CA, US
Cagent Vascular
Wayne, PA, US
Philips Electronics Ltd
Mississauga Ontario, CA
Nipro Vascular Corporation Aichi Facility
Seto Aichi, JP
Boston Scientific Limited
GALWAY, IE
Orbusneich Medical (shenzhen) Co., Ltd.
SHENZHEN Guangdong, CN
Brosmed Medical (malaysia) Sdn. Bhd.
Simpang Ampat Pulau Pinang, MY
510(k) clearances
45 clearances for this product code
- Bard Peripheral Vascular, Inc.Feb 4, 2026
K260012 · UltraScore Focused Force PTA Balloon
- Goodman Co., Ltd.Apr 22, 2025
K243944 · Aperta NSE PTA Balloon Dilatation Catheter
- Dk Medical Technology Co., Ltd.Apr 21, 2025
K242254 · D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter
- Brosmed Medical Co., Ltd.Oct 22, 2024
K241478 · Tri-Wedge PTA Scoring Balloon Dilatation Catheter
- Transit Scientific, LLCJun 17, 2024
K232258 · XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter
- Goodman Co., Ltd.Mar 28, 2024
K232013 · Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)
- Dk Medical Technology Co., Ltd.Mar 7, 2024
K232207 · D·Kutting PTA Scoring Balloon Dilatation Catheter
- Transit Scientific, LLCOct 18, 2022
K221986 · XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter