Medical Devices Recalls

Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.

Potential for breakage of the ECG electrode carbon stud from the eyelet.

Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased procedural time.

When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perform MR Flow combined with Left Ventricular Outflow Tract Flow (LVOT Flow) after performing an echocardiogram. The incorrect value is displayed. In addition, the error appears in the instruction manual

A software anomaly may occur with the clinician programmer application.

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deploying the bag upside down, which will make tissue encapsulation and bag closure more difficult, introducing the risk of trapping the small bowel/viscera in the bag at closure resulting in patient injury.

Two devices were labeled with the same serial number

Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

Holes in product packaging impacts package integrity and may compromise sterility.

RAPTAR units are capable of being field modified to enable the use of the higher power visible and IR laser pointers and the IR Illuminator.

Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

The values of the Internal Standard (IS) concentrations are incorrectly derived when the user builds a customized test, then set the IS column to hidden and left the column empty. This may lead to the user making incorrect conclusions using incorrect results.

The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.

Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.