Class I - Dangerous
The device was incorrectly packed in the wrong size labeled outer packaging.
LeMaitre Vascular
69 recalls • • Categories: Other Medical Devices, Surgical Instruments, Diagnostic Equipment, Infusion Pumps, Implants & Prosthetics
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
Class I - Dangerous
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Class I - Dangerous
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Class I - Dangerous
The guide tip can become damaged and result in the tip detaching.
Burrs (molding flash) on the cutter may tear the harvested vien
Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially becoming lost in the blood vessel.
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
incorrect device size being listed on the impacted device packaging
Class I - Dangerous
Pouches from this lot are not sealed compromising the sterility
The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distributed in the United States: 1) closure of arteriotomies and veinotomies, 2) attachment of synthetic vascular prostheses, and 3) approximation of dural tissue.
Class I - Dangerous
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Class I - Dangerous
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Class I - Dangerous
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Class I - Dangerous
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Class I - Dangerous
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Class I - Dangerous
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Class I - Dangerous
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Class I - Dangerous
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Class I - Dangerous
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Class I - Dangerous
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Class I - Dangerous
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Class I - Dangerous
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
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.
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Mislabeled with an incorrect expiration date
Blood blushing/leaking from the surface of the graft after implantation
Blood blushing/leaking from the surface of the graft after implantation
Blood blushing/leaking from the surface of the graft after implantation
Blood blushing/leaking from the surface of the graft after implantation
Blood blushing/leaking from the surface of the graft after implantation
Blood blushing/leaking from the surface of the graft after implantation
Blood blushing/leaking from the surface of the graft after implantation
Blood blushing/leaking from the surface of the graft after implantation
Blood blushing/leaking from the surface of the graft after implantation
Blood blushing/leaking from the surface of the graft after implantation
Blood blushing/leaking from the surface of the graft after implantation
Blood blushing/leaking from the surface of the graft after implantation
Blood blushing/leaking from the surface of the graft after implantation
Blood blushing/leaking from the surface of the graft after implantation
Blood blushing/leaking from the surface of the graft after implantation
Blood blushing/leaking from the surface of the graft after implantation
Blood blushing/leaking from the surface of the graft after implantation
Class I - Dangerous
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
Class I - Dangerous
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.