Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall. — Intuitive Surgical, Inc. · Class II · Ongoing · 11113
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. — Medtronic Perfusion Systems · Class II · Ongoing
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. — Abiomed, Inc. · Class I · Ongoing · 5,017 units
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN). — 3B Medical, Inc. · Class II · Ongoing · 375
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. — Abiomed, Inc. · Class I · Ongoing · 557 units
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. — Oscor Inc. · Class I · Ongoing · 32,934 units
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. — Abiomed, Inc. · Class I · Ongoing · 383 units
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. — Abiomed, Inc. · Class I · Ongoing · 96 units
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. — Abiomed, Inc. · Class I · Ongoing · 8,382 units
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. — Argon Medical Devices, Inc · Class I · Ongoing · 680
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. — Abiomed, Inc. · Class I · Ongoing · 196 units
Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product. — Nutricia North America · Class II · Ongoing · 1,363cs/12/12oz pouches + 16,298cs/24/12oz pouches