Stylet For Catheter, Gastro-urology
Gastroenterology, Urology · 21 CFR 876.5130
Recent MDR events
2,447 adverse event reports on file
- SensorJul 28, 2026MalfunctionBoston Scientific Corporation50052739
- SENSORJul 6, 2026MalfunctionBoston Scientific Corporation2124215-2026-36104
- NICORE NITINOL GUIDEWIREJun 26, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04159
- NiCore Nitinol GuidewireJun 26, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04171
- NICORE NITINOL GUIDEWIREJun 26, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04187
- SENSORJun 19, 2026MalfunctionBoston Scientific Corporation2124215-2026-32925
- SENSORJun 15, 2026OtherBoston Scientific CorporationMW5189416
- SENSORJun 15, 2026OtherBoston Scientific CorporationMW5189417
- NICORE NITINOL GUIDEWIREJun 5, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-03669
- AMPLATZ SUPER STIFFJun 5, 2026MalfunctionBoston Scientific Corporation2124215-2026-30262
Event type breakdown
Recalls
13 recall events for this product code
- Boston ScientificOpen, ClassifiedApr 1, 2020
Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Z-1729-2020 · View FDA record ↗ - Boston ScientificOpen, ClassifiedApr 1, 2020
Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Z-1730-2020 · View FDA record ↗ - Boston ScientificOpen, ClassifiedApr 1, 2020
Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Z-1731-2020 · View FDA record ↗ - Boston ScientificOpen, ClassifiedApr 1, 2020
Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Z-1732-2020 · View FDA record ↗ - Boston ScientificOpen, ClassifiedApr 1, 2020
Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Z-1733-2020 · View FDA record ↗ - Boston ScientificOpen, ClassifiedApr 1, 2020
Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Z-1734-2020 · View FDA record ↗ - Boston ScientificOpen, ClassifiedApr 1, 2020
Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Z-1735-2020 · View FDA record ↗ - Boston ScientificOpen, ClassifiedApr 1, 2020
Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Z-1736-2020 · View FDA record ↗ - Boston ScientificOpen, ClassifiedApr 1, 2020
Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Z-1737-2020 · View FDA record ↗ - Boston ScientificOpen, ClassifiedApr 1, 2020
Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Z-1738-2020 · View FDA record ↗
Registered firms
49 firms currently registered for this product code
Surgipros Llc
Palmetto, FL, US
Millennium Surgical Corp
Schaumburg, IL, US
Synergy Health Sterilisation Uk Ltd
Thorne Doncaster, GB
C.r. Bard, Inc.
Queensbury, NY, US
Applied Medical Europe
Amersfoort Utrecht, NL
Grace Manufacturing Inc
Russellville, AR, US
Allwin Medical Devices, Inc.
ANAHEIM, CA, US
Voma Ecza Deposu Medikal Urunler San. Tic. A.s.
IZMIR, TR
Boston Scientific Limited
GALWAY, IE
Integra Lifesciences Corporation
CINCINNATI, OH, US
Heraeus Medical Components, Srl
Guadalupe Cartago, CR
Boston Scientific Corporation
La Aurora Heredia, CR
Productos Para El Cuidado De La Salud
NOGALES Sonora, MX
Lake Region Medical Limited
NEW ROSS Wexford, IE
C.r. Bard, Inc.
COVINGTON, GA, US
Davol Surgical Innovations
CD. JUAREZ Chihuahua, MX
Jarit Gmbh
Rietheim-Weilheim Baden-Wurttemberg, DE
Steris Corporation
Saint Louis, MO, US
Allwin Medical Devices Pvt. Ltd.
Surat Gujarat, IN
Integra Lifesciences Corporation
Princeton, NJ, US
Applied Medical Resources Corp.
RSM, CA, US
Teleflex Medical De Mexico, S. De R.l. De C.v.
NUEVO LAREDO Tamaulipas, MX
Win Wings Corp.
SIALKOT Punjab, PK
Ilg Medizintechnik Gmbh
DURCHHAUSEN Baden-Wurttemberg, DE
Isomedix Operations, Inc.
Minneapolis, MN, US