Clip, Implantable

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2023-05-30Open, ClassifiedUnder Investigation by firm

  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.

• 2018-07-13TerminatedUnder Investigation by firm

  AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardica C-Port xA PLUS Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and conduit (e.g. saphenous vein graft). The stainless steel clips create a complete end-to-side anastomosis that is functionally equivalent to a hand-sutured interrupted stitch anastomosis. The system consists of one Anastomosis Device and one Retractor Mount.

  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.

• 2018-07-13TerminatedUnder Investigation by firm

  AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The Cardica C-Port Flex-A PLUS Distal Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel and conduit. The stainless steel clips create a complete end-to-side anastomosis that is functionally equivalent to a hand-sutured interrupted stitch anastomosis. The system consists of one Anastomosis Device and one Retractor Mount. The system is designed with a flexible shaft to facilitate access to difficult to reach coronary targets.

  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.

• 2016-05-06TerminatedNonconforming Material/Component

  Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

  Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.

• 2016-02-25TerminatedNonconforming Material/Component

  Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas. Hem-o-lok Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures.

  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.

• 2014-12-17TerminatedLabeling Change Control

  WECK Hemoclip Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice.

  The manufacturing dates and expiration dates were transposed on the Tyvek label.

• 2013-06-08TerminatedNonconforming Material/Component

  BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.

  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.

• 2012-10-18TerminatedPackaging process control

  Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709. Teleflex Medicals Hem-o-lok polymer ligating clips are single use, sterile, non-absorbable medial devices that have been designed to ligate vessels and tissue structures during various types of surgical procedures. Vessels and tissue structures in the range of 0.5 to 16 mm can be effectively ligated with Hem-o-lok clips.

  Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.

• 2010-07-17TerminatedOther

  Medtronic U-CLIP Double Arm Approximation Device, model V100D U-Clip, Catalog Number V100DRFRN2. Sterilized using Irradiation. The U-Clip consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may or may not include coils surrounding a Nitinol wire core. This design allows precise placement of clips prior to closure and facilitation from standard medical and implantable grade materials. Accessories include Clip delivery and removal devices as well as vessel cutting and retention tools. The Coalescent Surgical U-CLIP is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.

  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

• 2008-09-16TerminatedPackaging process control

  Weck Hemoclip Traditional Ligating Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709 USA. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and intended for the application of hemostatic clips during general open surgery. Ligation clips are non-absorbable to thermostatically restrict flow of fluids within vessels. Clips are removed from the cartridge and applied in such a manner as to engulf vessels. Teleflex Medical metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. Surgeons should select the size type, and material of the clip based upon their experience, judgment and needs.

  A hole in the sterile unit blister pack was detected that would compromise sterility.