Medical Devices Recalls

Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.

Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.

Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.

The needle cannula of a retractable needle may detach from the needle holder in the patient.

Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.

Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

Wrong product coloring. The paddle clips should be blank, but they are colored blue.

Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.

Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device is used during surgery, the boot may detach from the traction system, potentially leading to patient harm and a delay in surgery.

Product failed sterility testing.

Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.

Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.

Products not sterilized, sterility cannot be confirmed

Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

Products not sterilized, sterility cannot be confirmed

Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.

Products not sterilized, sterility cannot be confirmed