Medical Devices Recalls

Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installation involving 3M" Steri-Vac" Gas Sterilizers. The cause was traced to a rare situation involving a failure of the EO cartridge puncture assembly. This assembly was only in production during the period November 10, 2006 through December 14, 2007 and in service during the period February 7, 20

Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS.

The products are being recalled because they did not meet minimum needle attachment strength requirements.

Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS.

On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample.

Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the affected lots have a PowerPort Slim titanium implantable port without silicone suture plugs.

Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak, causing a system failure and possible drop out of the gantry system.

Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields

Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q biplane systems with a flat detector as 40 HDR (large 30x40).

The products are being recalled because they did not meet minimum needle attachment strength requirements.

Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results.

Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.

Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.

Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.

Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.