Pacemaker Lead Adaptor
Cardiovascular · 21 CFR 870.3620
Recent MDR events
741 adverse event reports on file
- Lead End Cap KitJul 31, 2026MalfunctionMedtronic Puerto Rico Villalba2649622-2026-22708
- Lead End Cap KitJul 31, 2026MalfunctionMedtronic Puerto Rico Villalba2649622-2026-22709
- pacemaker lead AdaptorJul 20, 2026InjuryAbbott Medical (crm-sylmar)2017865-2026-15213
- TRANSVENOUS LEADJul 17, 2026MalfunctionMedtronic Puerto Rico Villalba2649622-2026-21256
- LEAD ADAPTOR KITJun 3, 2026InjuryMedtronic Neuromodulation2182207-2026-01516
- LEAD ADAPTORMay 4, 2026MalfunctionMedtronic, Inc.MW5187661
- LEAD EXTENDER KITApr 7, 2026MalfunctionMedtronic, Inc.2182207-2026-00927
- IMPLANTABLE LEADMar 9, 2026InjuryOscor Medical / Oscor IncMW5184868
- LEAD END CAP KITFeb 26, 2026InjuryMedtronic Puerto Rico Villalba2649622-2026-05760
- RV(RIGHT VENTRICULAR) LEADFeb 23, 2026InjuryOscor Inc.MW5184166
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
31 firms currently registered for this product code
Medtronic, Inc.
Mounds View, MN, US
Oscor Inc.
PALM HARBOR, FL, US
Greatbatch Medical
Minneapolis, MN, US
International Sterilization Laboratory, Llc
GROVELAND, FL, US
Isomedix Operations, Inc.
Minneapolis, MN, US
Medtronic Puerto Rico Operations Co., Villalba
Villalba, PR, US
Biotronik Se & Co. Kg
BERLIN, DE
Biotronik, Inc.
LAKE OSWEGO, OR, US
Oscor Caribe Llc
SANTO DOMINGO Distrito Nacional, DO
Isomedix Operations, Inc.
Temecula, CA, US
Heraeus Medical Components Caribe, Inc.
DORADO, PR, US
510(k) clearances
103 clearances for this product code
- Oscor, Inc.Mar 19, 2015
K143463 · IS4/DF4 Port Plug
- Medtronic, Inc.Jul 30, 2013
K132008 · 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP
- Guidant CorporationJul 12, 2004
K041574 · CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020
- Oscor, Inc.Jun 19, 2003
K031164 · PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV
- Oscor, Inc.Jan 14, 2003
K024156 · PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR
- Oscor, Inc.May 22, 2001
K010787 · PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS
- Biotronik, Inc.Jan 18, 2001
K003454 · A1-CS-SB Y-ADAPTER, MODEL 124 871
- Medtronic VascularFeb 23, 2000
K000210 · MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT