Applier, Hemostatic Clip

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

• 2014-03-14TerminatedNonconforming Material/Component

  Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial appendage.

  The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.

• 2010-10-28TerminatedPackaging change control

  LeMaitre Vascular AnastoClip GC Vessel Closure System-Medium Size Models: 4007-02 Medium size 3 Pack 4008-02 Medium size 10 Pack 4007-06 Medium size 1 Pack Manufactured by LeMatire Vascular Inc, Burlington, MA 01803

  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.

• 2010-10-28TerminatedPackaging change control

  LeMaitre Vascular AnastoClip GC Vessel Closure System-Large Size Models: 4007-03 Large size 3 Pack 4008-03 Large size 10 Pack 4007-07 Large size 1 Pack Manufactured by LeMatire Vascular Inc, Burlington, MA 01803

  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.

• 2009-01-13TerminatedPackaging process control

  Multi-Clip Applier Model #'s: APPCA080 AUT134031 AUT134046 AUT134051 AUT134053 AUT176625 AUT176657 AUTPTACK30 ETHEL5ML ETHER320 ETHMCL20 ETHMCM20 ETHMCM30 ETHMCS20 ETHMSM20 and WEC543965 A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either resusable or disposable, intended to be used in various general surgical procedures.

  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

• 2004-10-22TerminatedOther

  Hem-o-lok Endo5 Ligation Applier

  The jaws may break during clip loading or clip application.

• 2004-08-24TerminatedOther

  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.

• 2004-08-24TerminatedOther

  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.

• 2004-08-24TerminatedOther

  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.

• 2004-08-24TerminatedOther

  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.

• 2004-08-24TerminatedOther

  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.