Medtronic Vascular Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT recall — FDA Z-0291-2022
Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
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Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result…
The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed.
Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient,…
Products that were on HOLD for potential foreign materials was accidently released into commerce. The products released may be contaminated with small plastic foreign material.
Product may be contaminated with foreign objects (plastic fragments)
Product may be contaminated with foreign objects (plastic fragments)
Internal testing found the presence of Pseudomonas aeruginosa in the product.
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Honda (American Honda Motor Co.) is recalling certain 2019 Passport, 2016-2019 Pilot, and 2017-2020 Ridgeline vehicles. The hood latch striker may become damaged and separate from the hood,…
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of…
System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7…
There is a risk of breakage of the torque limiting adaptor if used counterclockwise and it must not be used with a power tool due to no test data validating this use.
Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any…
Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect…
Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any…
There is a potential for distal tip dislodgement or separation.
Some affected wheelchairs, with transit tie downs, that are used as a passenger seat in a motor vehicle may not be configured in the right orientation to perform as intended if involved in…
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of…
Due to a component in kit being labeled with the incorrect Expiration Date
The labels on the packages of screws were switched.
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