Recalls for Clip, Implantable

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.

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.

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.

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

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.

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

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.

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

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

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

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

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

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

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

Medtronic has identified one lot #0610315 of U-Clip Removal Tools, Catalog UREM1860FW, that was incorrectly assembled. The nose cone attachment, on the body of the removal tool, may not contain sufficient adhesive, which can allow the nose cone to separate from the body of the device.

Six lots of U-Clip Removal Tools, catalog REM1860FW were incorrectly assembled. The nose cone attachment to the body of the removal tool does not contain sufficient adhesive which can cause the nose to separate from the body of the device.

The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephrectomies in living donor patients.

The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephrectomies in living donor patients.

The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephrectomies in living donor patients.

The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephrectomies in living donor patients.

Customers stated that the U-Clip deployment collar was either difficult to rotate or 'locks up' during usage, which prevents the deployment of the U-Clips.

The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.

The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.

The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.

The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.

Malformation of the Hem-o-lok SMX clip.

The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier.

Device malfunction causing the applier to jam, and clip loading failures.

There is a potential for a component failure of the device which could necessitate medical intervention.

Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).

Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).

A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility.

A complaint of the PRO2 jaw breaking prior to surgery being performed.

Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. A publication from 2017 recommended Aesculap DS Clips for kidney transplantation with living donors. The information from this publication was not approved or validated by the firm.

Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. Updated cleaning and sterilization instructions.

US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use

US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

The manufacturing and expiration dates are not printed on the blister pack label.

Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery

Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery