Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate...
Reason: Edwards Lifesciences is recalling certain Proplege Coronary Sinus Catheter, model PR9 due to confirmed reports of blood leakage through the hemostasis valve in the introducer that ...
Z-1322-2013May 22, 2013Draper, UT
Cook, Inc.
Class ITerminated
Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with t...
Reason: Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system i...
Z-1275-2013May 22, 2013Bloomington, IN
Smiths Medical ASD, Inc.
Class IITerminated
Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator Product Code: PEB623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity fo...
Reason: Unable to pass catheter through outer sheath during embryo transfer
Z-1240-2013May 15, 2013Keene, NH
Smiths Medical ASD, Inc.
Class IITerminated
Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following i...
Reason: Unable to pass catheter through outer sheath during embryo transfer
Z-1242-2013May 15, 2013Keene, NH
Smiths Medical ASD, Inc.
Class IITerminated
Wallace Sure-Pro¿ Single Stage Embryo Replacement Catheter Product Code: PP623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following ...
Reason: Unable to pass catheter through outer sheath during embryo transfer
Z-1244-2013May 15, 2013Keene, NH
Smiths Medical ASD, Inc.
Class IITerminated
Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Stylet Product Code:PES623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity follow...
Reason: Unable to pass catheter through outer sheath during embryo transfer
Z-1241-2013May 15, 2013Keene, NH
Baxter Healthcare Corp.
Class IITerminated
A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use ...
Reason: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
Z-1269-2013May 15, 2013Deerfield, IL
Smiths Medical ASD, Inc.
Class IITerminated
Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter for difficult transfer with Stylet PPS623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine...
Reason: Unable to pass catheter through outer sheath during embryo transfer
Z-1243-2013May 15, 2013Keene, NH
Smiths Medical ASD, Inc.
Class IITerminated
Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uteri...
Reason: Unable to pass catheter through outer sheath during embryo transfer
Z-1239-2013May 15, 2013Keene, NH
Baxter Healthcare Corp.
Class IITerminated
A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol...
Reason: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
Z-1268-2013May 15, 2013Deerfield, IL
Baxter Healthcare Corp.
Class IITerminated
A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabiliza...
Reason: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
Z-1270-2013May 15, 2013Deerfield, IL
Baxter Healthcare Corp.
Class IITerminated
A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV extension tubing kit...
Reason: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
Z-1271-2013May 15, 2013Deerfield, IL
Teleflex Medical
Class IITerminated
Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects urine by mechanical means when attached to an indwelling Foley or suprapubic catheter.
Reason: Sterile packaging may be compromised.
Z-1158-2013May 1, 2013Durham, NC
Elana, Inc.
Class IITerminated
Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.
Reason: Distribution of an unapproved device into interstate commerce.
Z-1143-2013April 24, 2013Columbia, MD
Edwards Lifesciences, LLC
Class IITerminated
Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
Reason: Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by custo...
Z-1135-2013April 24, 2013Draper, UT
Edwards Lifesciences, LLC
Class IITerminated
Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
Reason: Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by custo...
Z-1134-2013April 24, 2013Draper, UT
AGFA Corp.
Class IITerminated
IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric e...
Reason: Software design error in IMPAX CV 7.8 SU3
Z-1069-2013April 17, 2013Greenville, SC
Arrow International Inc
Class IITerminated
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
Reason: Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.
Z-1064-2013April 17, 2013Reading, PA
AGFA Corp.
Class IITerminated
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
Reason: Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic healt...
Z-1070-2013April 17, 2013Greenville, SC
Arrow International Inc
Class IITerminated
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
Reason: Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.
Z-1065-2013April 17, 2013Reading, PA
Arrow International Inc
Class IITerminated
Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheter...
Reason: The product specifications sheet, part of the Instructions for Use (IFU), for the specified product numbers, reference Renografin-76 contrast medium (viscosity of 8.4 centipoise), ...
Z-1057-2013April 10, 2013Reading, PA
Medtronic Inc. Cardiac Rhythm Disease Management
Class IITerminated
Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.
Reason: Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating has the potential to...
Z-1017-2013April 3, 2013Saint Paul, MN
Biosense Webster, Inc.
Class IITerminated
20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.
Reason: Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connected to an affected to an affected 20-Pole Eco Cable, the catheter will ...
Z-1023-2013April 3, 2013Irwindale, CA
Medtronic Inc. Cardiac Rhythm Disease Management
Class IITerminated
Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. Product Usage: The Medtronic Archer 0.035 inch (0.89mm) Su...
Reason: Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W, wher...
Z-1019-2013April 3, 2013Saint Paul, MN
Vygon Corporation
Class IITerminated
Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.
Reason: Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.