Medical equipment, implants, and diagnostic devices
Maquet Cardiovascular
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
Abbott Point Of Care
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Boston Scientific
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
WASATCH PHOTONICS
Two new potential laser safety failure modes have been identified in the product design. Overcurrent of laser diode, and a fail-unsafe mode. The failure modes have never been found to occur in these models, whether in the field or factory, but could potentially occur under excessive force or extreme, continuous vibration.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Boston Scientific
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Siemens Medical Solutions USA
Limited system movements after startup .
Philips Medical Systems Nederland B.V.
Software issue that results in the display of outdated information.
Measles IgM Test Kit lacks premarket approval or clearance.
Dipstick strep A test has potential for false positive results.
Olympus Corporation of the Americas
Potential for undetected, deformed a-traumatic tips.
A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.
Potential for open header bag seals, compromising sterility.
SEASPINE ORTHOPEDICS
Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Boston Scientific
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Failure of fusion system instruments in the field.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
CORNEAT VISION
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.