Applier, Hemostatic Clip
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
362 adverse event reports on file
- APPLIER, HEMOSTATIC CLIPApr 7, 2026MalfunctionEthicon Endo-surgery, Llc.3005075853-2026-02617
- LIGACLIP*ENDO MED/LG APPLIERFeb 9, 2026MalfunctionEthicon Endo-surgery, Llc.3005075853-2026-01149
- LIGACLIP*ENDO MED/LG APPLIERDec 17, 2025MalfunctionEthicon Endo-surgery, Llc.3005075853-2025-09586
- LIGACLIP*ENDO MED/LG APPLIERDec 17, 2025MalfunctionEthicon Endo-surgery, Llc.3005075853-2025-09587
- LIGACLIP*ENDO MED/LG APPLIERApr 30, 2025MalfunctionEthicon Endo-surgery, Llc.3005075853-2025-03154
- LIGACLIP*ENDO MED/LG APPLIERApr 22, 2025MalfunctionEthicon Endo-surgery, Llc.3005075853-2025-02842
- LIGACLIP*ENDO MED/LG APPLIERApr 22, 2025MalfunctionEthicon Endo-surgery, Llc.3005075853-2025-02841
- LIGACLIP*ENDO MED/LG APPLIERApr 1, 2025MalfunctionEthicon Endo-surgery, Llc.3005075853-2025-02423
- WECK HEM-O-LOK LARGEFeb 6, 2025MalfunctionTeleflex MedicalMW5165791
- LIGACLIP*ENDO MED/LG APPLIERDec 12, 2024MalfunctionEthicon Endo-surgery, Llc.3005075853-2024-09505
Event type breakdown
Recalls
14 recall events for this product code
- Atricure IncTerminatedMar 14, 2014
Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069.
The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
Z-1209-2014 · View FDA record ↗ - Lemaitre Vascular, Inc.TerminatedOct 28, 2010
LeMaitre Vascular AnastoClip GC Vessel Closure System-Medium Size
Mislabeled size on external packaging: The contents section listed on the Tyvek lid labels of the Medium and Large sizes incorrectly identified the size of the clip as XL, while the device inside was either a Medium or Large size.
Z-0164-2011 · View FDA record ↗ - Lemaitre Vascular, Inc.TerminatedOct 28, 2010
LeMaitre Vascular AnastoClip GC Vessel Closure System-Large Size
Mislabeled size on external packaging: The contents section listed on the Tyvek lid labels of the Medium and Large sizes incorrectly identified the size of the clip as XL, while the device inside was either a Medium or Large size.
Z-0165-2011 · View FDA record ↗ - Sterilmed IncTerminatedJan 13, 2009
Multi-Clip Applier
SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable
Z-0564-2009 · View FDA record ↗ - WeckTerminatedOct 22, 2004
Hem-o-lok Endo5 Ligation Applier
The jaws may break during clip loading or clip application.
Z-0031-05 · View FDA record ↗ - WeckTerminatedAug 24, 2004
Ref No. 523170 Hemoclip, 15 Large Tantalum Clips/Cartridge and Ref. No. 523370 Hemoclip 10 Large Tantalum Clips/Cartridge
Hole in the sterile unit blister pack that could compromise sterility.
Z-1385-04 · View FDA record ↗ - WeckTerminatedAug 24, 2004
Ref. No. 121505 Atrauclip, 15 Large Titanium Clips/Cartridge and Ref. No. 121506 Atrauclip, 10 Large Titanium Clips/Cartridge
Hole in the sterile unit blister pack that could compromise sterility.
Z-1386-04 · View FDA record ↗ - WeckTerminatedAug 24, 2004
Ref. No. 523770 Hemoclip, 15 Large Titanium Clips/Cartridge, and Ref. No. 523870 Hemoclip 10 Large Titanium Clips/Cartridge
Hole in the sterile unit blister pack that could compromise sterility.
Z-1387-04 · View FDA record ↗ - WeckTerminatedAug 24, 2004
Ref. No. 523171 Hemoclip, 10 Large Tantalum Clips/Cartridge (Non-Sterile) and Ref. No. 523371 Hemoclip, 15 Large Tantalum Clips/Cartridge (Non-Sterile)
Hole in the sterile unit blister pack that could compromise sterility.
Z-1388-04 · View FDA record ↗ - WeckTerminatedAug 24, 2004
Ref. No. 523771 - Hemoclip, 15 Large Titanium Clips/Cartridge (Non-Sterile) and Ref. No. 523871- Hemoclip, 10 Large Titanium Clips/Cartridge (Non-Steile)
Hole in the sterile unit blister pack that could compromise sterility.
Z-1389-04 · View FDA record ↗
Registered firms
77 firms currently registered for this product code
Lemaitre Vascular, Inc.
BURLINGTON, MA, US
Integra Lifesciences Production Corporation
Mansfield, MA, US
Rebstock Instruments Gmbh
DUERBHEIM Baden-Wurttemberg, DE
Dimeda Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Black & Black Surgical, Inc.
Tucker, GA, US
Hive International Pvt Ltd.
Sialkot Punjab, PK
Lemaitre Vascular Inc.
Billerica, MA, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Wexler Surgical, Inc.
HOUSTON, TX, US
Mainline Medical Dental Supply
North York Ontario, CA
Tecomet, Inc.
KENOSHA, WI, US
Hebumedical Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Conmed Corporation
Utica, NY, US
Med2b Ltd.
Kitzingen Bavaria, DE
Mizuho Corporation Gosen Factory
Gosen Niigata, JP
Post Surgical Mfg.
Hauppauge, NY, US
Choose Surgical Instruments
Sialkot Punjab, PK
Meed Skills Surgical
SIALKOT Punjab, PK
Teleflex Medical Llc
Morrisville, NC, US
Aspen Surgical Products, Inc.
Caledonia, MI, US
Hangzhou Sunstone Technology Co., Ltd.
Hangzhou Zhejiang, CN
Technimen Skillers
SIALKOT Punjab, PK
Itm Industria De Tecnologias Medicas Ltda
CANOAS Rio Grande do Sul, BR
Alira Medical Devices Llc
Rancho Cucamonga, CA, US
Nanova Biomaterials Inc
Columbia, MO, US
510(k) clearances
4 clearances for this product code
- Richard-Allan MedicalJul 21, 1993
K924929 · REFLEX(R) ECA
- Richard-Allan Medical Ind., Inc.Jan 2, 1990
K896262 · TITANIUM LIGATING CLIPS
- Downs Surgical , Ltd.Jul 30, 1986
K862696 · TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP
- Edward Weck, Inc.Mar 10, 1980
K800318 · DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI