Medical device 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.

Marketed without FDA clearance

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.

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.

During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of infection.

Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential for the plunger to draw back after air has been expelled and reintroduce air back into the syringe.

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

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.

The firm has confirmed the potential for Atellica CH 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.

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

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

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

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.

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.

If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error messages during the treatment and possible mis-treatment.

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.

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.

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.

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.

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.

Two devices were labeled with the same serial number

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.

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.

Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.