CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.
Reason: A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa...
Z-0590-2020December 18, 2019Bloomington, IN
Boston Scientific Corporation
Class IITerminated
NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493926708350, NC EMERGE MR US 3.50MM X 8MM; 2. REF/Catalog ...
Reason: Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices,...
Z-0579-2020December 4, 2019Maple Grove, MN
Boston Scientific Corporation
Class IITerminated
Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H74...
Reason: Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices,...
Z-0577-2020December 4, 2019Maple Grove, MN
Spectranetics Corporation
Class IITerminated
Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremon...
Reason: The incorrect outer carton box was used for the product.
Z-0576-2020December 4, 2019Fremont, CA
Boston Scientific Corporation
Class IITerminated
Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070, 7F.
Reason: Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices,...
Z-0578-2020December 4, 2019Maple Grove, MN
Boston Scientific Corporation
Class IITerminated
Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chromium (PtCr) Alloy st...
Reason: Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices,...
Reason: A complaint was received regarding kinking of the device prior to use. If a device is kinked it cannot be used. In addition, the company became aware that the device had been used ...
Z-0512-2020December 4, 2019Washington
Bard Peripheral Vascular Inc
Class IIOngoing
PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
Reason: Complaints received that products packaged with the incorrect introducer sheath size.
Z-0582-2020December 4, 2019Tempe, AZ
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Class IITerminated
4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
Reason: Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.
Z-0585-2020December 4, 2019Dover, NH
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0439-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0442-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0450-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
Reason: Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected ...
Z-0415-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0485-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0455-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0428-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0488-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Reason: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connec...
Z-0504-2020November 27, 2019Glens Falls, NY
Angiodynamics Inc. (Navilyst Medical Inc.)
Class IITerminated
XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to h...
Reason: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connec...
Z-0505-2020November 27, 2019Glens Falls, NY
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0445-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0458-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0459-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0423-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.