Medtronic Perfusion Systems recalls Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR
Certain lots of product have the potential for a sterile barrier breach.
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 889–900 of 4,960 recalls
Certain lots of product have the potential for a sterile barrier breach.
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and…
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption…
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest.…
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration.…
Incomplete seals on sterile product
Incomplete seals on sterile product
Incomplete seals on sterile product