Clip, Implantable
General, Plastic Surgery · 21 CFR 878.4300
Recent MDR events
42,204 adverse event reports on file
- ENDO CLIP IIJul 31, 2026MalfunctionDavis & Geck Caribe Ltd9612501-2026-02081
- LIGAMAXJul 31, 2026MalfunctionEthicon Endo-surgery, Llc.3005075853-2026-06035
- ENDO CLIP IIJul 31, 2026MalfunctionDavis & Geck Caribe Ltd9612501-2026-02085
- ENDO CLIPJul 31, 2026MalfunctionDavis & Geck Caribe Ltd9612501-2026-02089
- ENDO CLIP IIIJul 31, 2026MalfunctionDavis & Geck Caribe Ltd9612501-2026-02092
- ENDO CLIP IIIJul 31, 2026MalfunctionDavis & Geck Caribe Ltd9612501-2026-02094
- ENDO CLIPJul 31, 2026MalfunctionDavis & Geck Caribe Ltd9612501-2026-02095
- ENDO CLIPJul 31, 2026MalfunctionDavis & Geck Caribe Ltd9612501-2026-02096
- ENDO CLIP IIIJul 31, 2026MalfunctionDavis & Geck Caribe Ltd9612501-2026-02101
- ENDO CLIP IIIJul 31, 2026MalfunctionDavis & Geck Caribe Ltd9612501-2026-02102
Event type breakdown
Recalls
45 recall events for this product code
- TELEFLEX LLCOpen, ClassifiedMay 30, 2023
Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation
Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that restricts the application of the clip to the applier. With this step feature missing on the cartridge, the clip is mounted in a more variable position, allowing the clips to load farther back in the clip applier jaw grooves. This may potentially result in inappropriate or inadequate clip application to vascular structures.
Z-1663-2023 · View FDA record ↗ - AESDEXTerminatedJul 13, 2018
AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100.
Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components.
Z-2433-2018 · View FDA record ↗ - AESDEXTerminatedJul 13, 2018
AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150
Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components.
Z-2434-2018 · View FDA record ↗ - Applied Medical Resources CorpTerminatedMay 6, 2016
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.
Z-1621-2016 · View FDA record ↗ - Teleflex MedicalTerminatedFeb 25, 2016
Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965
The clip in the applier may be missing a boss. A boss is the part of the clip that is used to hold the clip within the applier jaws prior to application.
Z-0886-2016 · View FDA record ↗ - Teleflex MedicalTerminatedDec 17, 2014
WECK Hemoclip Traditional Medium Tantalum Ligating Clips.
The manufacturing dates and expiration dates were transposed on the Tyvek label.
Z-0826-2015 · View FDA record ↗ - Bard Peripheral Vascular IncTerminatedJun 8, 2013
BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker.
Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / lot number combination may have the metal tissue marker separated from the needle prior to use.
Z-1524-2013 · View FDA record ↗ - Teleflex MedicalTerminatedOct 18, 2012
Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709.
Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.
Z-0078-2013 · View FDA record ↗ - Medtronic Cardiovascular Revascularization & Surgical TherapTerminatedJul 17, 2010
Medtronic U-CLIP Double Arm Approximation Device, model V100D U-Clip, Catalog Number V100DRFRN2. Sterilized using Irradiation. The U-Clip consists of speciall
Medtronic received reports involving the V100D U-Clip where during handling, the release mechanism has become separated from the needle assembly. These instances of separation have occurred when pulling the clip through prosthetic material, or when grasping and releasing the clip using robotic instrumentation. While this issue does not impact performance of the clip once implanted, separation of
Z-2030-2010 · View FDA record ↗ - Telefelx MedicalTerminatedSep 16, 2008
Weck Hemoclip Traditional Ligating Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709 USA. The use of the reusable Teleflex Medical metal ligating clips
A hole in the sterile unit blister pack was detected that would compromise sterility.
Z-0156-2009 · View FDA record ↗
Registered firms
310 firms currently registered for this product code
Neuramedica Inc.
Oregon City, OR, US
Sterigenics U.s., Llc
Atlanta, GA, US
Covidien
North Haven, CT, US
Ethicon Endo-surgery, Llc
GUAYNABO, PR, US
Medtronic Distribution Center
Memphis, TN, US
Mediplast Israel Ltd
Yavne Tel Aviv, IL
Zimmer Biomet Korea Ltd.
Seoul, KR
C.r. Bard, Inc.
MADISON, GA, US
Teleflex Medical De Tecate, S. De R.l De C.v.
TECATE Baja California, MX
Voma Ecza Deposu Medikal Urunler San. Tic. A.s.
IZMIR, TR
Taiwan Surgical Corporation
Zhubei City Hsinchu, TW
Lemaitre Vascular, Inc.
BURLINGTON, MA, US
Sterigenics Radiation Technologies, Llc
San Diego, CA, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Medline Industries, Lp - Northfield
Northfield, IL, US
Bard Peripheral Vascular, Inc.
TEMPE, AZ, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Burak Global Ic Ve Dis Tic Ltd Sti
Kocasinan Kayseri, TR
510(k) clearances
177 clearances for this product code
- Taiwan Surgical CorporationJul 20, 2026
K254231 · Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips
- Taiwan Surgical CorporationDec 22, 2025
K253903 · InnoClip Disposable Clip Applier
- Taiwan Surgical CorporationDec 22, 2025
K253781 · InnoClip Clip Applier
- Hangzhou Kangji Medical Instrument Co., Ltd.Nov 20, 2025
K250643 · Disposable Polymer Ligation Clips
- Teleflex MedicalJul 3, 2025
K251054 · Hem-o-lok PurplePlus Large Polymer Ligating Clips
- Synovis Micro Companies Alliance A Subsidiary of Baxter IntJan 15, 2025
K242541 · GEM ZIPCLIP
- Medscope Biotech Co., Ltd.Jul 18, 2024
K221495 · SOLID CLIP Single Use Clip Applier
- Teleflex MedicalJan 12, 2024
K232970 · Hem-o-lok® Ligating Clips