Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of devices intended for the administration of an analgesic or anesthetic agent to the epi...
Reason: Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of...
Reason: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Z-1052-2024February 28, 2024Waukegan, IL
B. Braun Medical, Inc.
Class IIOngoing
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray (Kit)-A collection of devices intended for the administratio...
Reason: Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of ...
Z-1149-2024February 28, 2024Allentown, PA
W.L. Gore & Associates, Inc.
Class IIOngoing
GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes
Reason: Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unp...
Reason: New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of...
Reason: IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.
Reason: The microcatheter IFU contains an intended use that has not been evaluated by the FDA.
Z-1085-2024February 21, 2024Salt Lake City, UT
BALT USA, LLC
Class IIOngoing
The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral va...
Reason: Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of sold...
Z-1042-2024February 14, 2024Irvine, CA
BALT USA, LLC
Class IIOngoing
Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and o...
Reason: Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of sold...
Z-1041-2024February 14, 2024Irvine, CA
American Contract Systems, Inc.
Class IIOngoing
Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G; b) TAVR PACK, kit number LLTV10; c) CATH PED LF SJH, kit number SJCA21F; ...
Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu...
Z-0817-2024February 7, 2024Temple Terrace, FL
St. Jude Medical, Atrial Fibrillation Division, Inc.
Class IIOngoing
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
Reason: When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a...
Z-0814-2024January 31, 2024Saint Paul, MN
Abiomed, Inc.
Class IIOngoing
Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3056
Reason: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to th...
Z-0654-2024January 17, 2024Danvers, MA
Abiomed, Inc.
Class IIOngoing
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 Individual, and Part of Pump Set (005062, 0550-0008,...
Reason: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to th...
Z-0646-2024January 17, 2024Danvers, MA
Abiomed, Inc.
Class IIOngoing
Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the b...
Reason: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to th...
Z-0649-2024January 17, 2024Danvers, MA
Abiomed, Inc.
Class IIOngoing
Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025
Reason: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to th...
Z-0653-2024January 17, 2024Danvers, MA
Abiomed, Inc.
Class IIOngoing
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-...
Reason: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to th...
Z-0652-2024January 17, 2024Danvers, MA
Bard Peripheral Vascular Inc
Class IIOngoing
BD Recanalization System, REF: BDRECANSYSTEM
Reason: Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart require...
Z-0676-2024January 17, 2024Tempe, AZ
Abiomed, Inc.
Class IIOngoing
Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3014
Reason: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to th...
Z-0647-2024January 17, 2024Danvers, MA
Abiomed, Inc.
Class IIOngoing
Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3052
Reason: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to th...
Z-0650-2024January 17, 2024Danvers, MA
Abiomed, Inc.
Class IIOngoing
Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-0053
Reason: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to th...
Z-0651-2024January 17, 2024Danvers, MA
Abiomed, Inc.
Class IIOngoing
Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 2000342
Reason: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to th...