Medical Devices Recalls

The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.

Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.

The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.

The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays (Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.

Internal testing results showed endotoxin-related test result did not meet specifications for implantable insulin pump. If pumps have higher than allowed endotoxin levels, patients may have an effect of fever, hypotension, anaphylactic shock, hyperglycemia, or diabetic ketoacidosis (DKA), potentially followed by secondary multi-organ failure (primarily renal and hepatic) and/or death.

Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.

The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery.

Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrect quantification of vessel detection and result in an incorrect diagnosis and inappropriate treatment of the patient

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback.

The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.

The surgical gowns were manufactured in a facility that is not registered by the FDA.

Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from the field showed that in case of Clot Detection error, this management may lead to the dilution of the Primary Tube with the distilled water of the hydraulic circuit of the Aliquoter Module.

The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

The surgical gowns were manufactured in a facility that is not registered by the FDA.

Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.