Stylet, Catheter
Cardiovascular · 21 CFR 870.1380
Recent MDR events
1,275 adverse event reports on file
- LLD E Lead Locking DeviceJul 30, 2026InjurySpectranetics Corporation3007284006-2026-00408
- Liberator® Beacon® Tip Locking StyletJul 30, 2026MalfunctionMerit Medical Ireland, Ltd.9616662-2026-00070
- LLD EZ LEAD LOCKING DEVICEJul 22, 2026InjurySpectranetics Corporation3007284006-2026-00398
- LLD EZ LEAD LOCKING DEVICEJul 22, 2026DeathSpectranetics Corporation3007284006-2026-00399
- LLD EZ LEAD LOCKING DEVICEJul 21, 2026InjurySpectranetics Corporation3007284006-2026-00395
- LLD #2 LEAD LOCKING DEVICEJul 21, 2026InjurySpectranetics Corporation3007284006-2026-00400
- LLD EZ LEAD LOCKING DEVICEJul 21, 2026InjurySpectranetics Corporation3007284006-2026-00401
- ADJUSTABLE SLITTER, GUIDE CATHETERJul 13, 2026MalfunctionMedtronic, Inc.2182208-2026-43045
- LLD E LEAD LOCKING DEVICEJun 30, 2026InjurySpectranetics Corporation3007284006-2026-00386
- LLD EZ LEAD LOCKING DEVICEJun 25, 2026DeathSpectranetics Corporation3007284006-2026-00383
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
54 firms currently registered for this product code
Medtronic Puerto Rico Operations Co., Villalba
Villalba, PR, US
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
Merit Medical Systems, Inc.
South Jordan, UT, US
Philips Electronics Ltd
Mississauga Ontario, CA
Spectranetics Corp.
Colorado Springs, CO, US
Biotronik, Inc.
LAKE OSWEGO, OR, US
St. Jude Medical Coordination Center Bvba European Distribution Center
BruCargo Vlaams Brabant, BE
Merit Medical Asia Company Limited
Tsim Sha Tsui, HK
Abbott Medical
Sylmar, CA, US
Covidien
TIJUANA, B.C. Mexico, MX
Teleflex Medical De Mexico, S. De R.l. De C.v.
NUEVO LAREDO Tamaulipas, MX
Terumo Bct Sterilization Services, Inc.
LAKEWOOD, CO, US
Merit Medical Nederland Bv
Maastricht Airport Limburg, NL
Teleflex Medical Llc
Morrisville, NC, US
Merit Medical Australia Pty Ltd.
Braiside Victoria, AU
Boston Scientific Corporation
Saint Paul, MN, US
Medxl
ARDMORE, OK, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Isomedix Operations, Inc.
Temecula, CA, US
Merit Medical Ireland, Ltd
Galway, IE
Sterigenics U.s., Llc
Santa Teresa, NM, US
Arrow International Llc (subsidiary Of Teleflex Incorporated)
Morrisville, NC, US
Cardinal Health Costa Rica, S.a.
-- Alajuela, CR
510(k) clearances
28 clearances for this product code
- Arrow International, LLC (A subsidiary of Teleflex, Inc.)Aug 30, 2022
K220280 · Arrow Stiffening Stylet
- Biotronik, Inc.Aug 1, 2019
K191469 · Biotronik Stylets
- Galt Medical Corp.May 30, 2019
K182660 · GaltTWS
- Cook IncorporatedOct 18, 2017
K170298 · Liberator Beacon Tip Locking Stylet
- Spectranetics, Inc.Aug 12, 2014
K142116 · LLD EZ
- St Jude MedicalApr 1, 2009
K090163 · STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
- St. Jude Medical, Cardiac Rhythm Management DivisiApr 30, 2008
K080924 · MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151
- St. Jude Medical, Cardiac Rhythm Management DivisiMar 13, 2008
K072864 · ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM