434 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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BD Exacta 6Fr Percutaneous Sheath Introducer Tray.
FDA Recall
Terminated
·Becton Dickinson Infusion Therapy·Product code DYB·January 10, 2005
Arrow ARROWg+ard Super Arrow-Flex Percutaneous Sheath Introducers
FDA Recall
Terminated
·Arrow International Inc·Product code DYB·February 11, 2009
Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada Highway, Montreal, QC, Canada H4T1A1, (514) 488-9802; INCLUDES: One (1) Radiopaque Sheath, One (1) Radiopaque Dilator; And One (1) B* x 135 cm Guidewire. Intended to allow left heart catheterization procedure to occur through the right atrium.
FDA Recall
Terminated
·Baylis Medical Corp·Product code DYB·February 8, 2010
Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side Port, for the introduction of various types of pacing or defibrillator leads and catheters. The product is shipped 5 per carton. Product is distributed by Pressure Products. Catalog numbers: CSG/MSP-00-09, CSG/90-09, CSG-KR-90-09, CSG/WORLEY-1-09, CSG-WORLEY-Bcor-1-09, CSG/WORLEY/L/Bcor-1-09, CSG/WORLEY-2-09, CSG/WORLEY/Bcor-2-09, CSGMSP0009M, CSGWORLEY109M, CSGWORL19M, CSGWORBC19M, CSGWORLBC19M, CSGWORBC29M, CSG/Worley/BCor-1-07, CSG/Worley/BCor-2-07, CSG/WORLEY/BCOR-M-09, and CSG/Worley/R-1-09.
FDA Recall
Terminated
·Thomas Medical Products Inc·Product code DYB·December 17, 2009
AngioDynamics 15F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507602
FDA Recall
Terminated
·MedAmicus, Inc·Product code DYB·June 6, 2003
Medamicus FlowGuard 16 FR Valved Peelable Introducer Kit, Catalog Number 10532-011
FDA Recall
Terminated
·MedAmicus, Inc·Product code DYB·June 6, 2003
SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1007. The product is shipped in cartons containing 5 units
FDA Recall
Terminated
·Thomas Medical Products Inc·Product code DYB·October 14, 2004
Peel-Away Introducer set, 7.0 FR; includes sheath: 7.0 FR., Catheter introducer, 9 CM long, Wire: .035" DIA., 30 CM long, 3 MM J needle: 18 ga., 4.0 cm long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLIP-7.0-35. Cook Inc., Bloomington, IN 47404
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·December 7, 2007
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408527, 100028094.
FDA Recall
Terminated
·St. Jude Medical Cardiovascular Division·Product code DYB·June 28, 2010
Thomas Medical Products, SafeSheath Long, (Tear-Away Sheath Introducer Set with Integral Hemostasis Valve) for use during vascular interventional procedures. Part No. FCL-051-00, Catalog No. HLS2507MCN; and Part No. FCL-051-02, Catalog No. HLS2507MCN.
FDA Recall
Terminated
·Thomas Medical Products Inc·Product code DYB·December 16, 2010
COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-15.0-SC
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·November 25, 2002
COOK Stiffened Micropuncture Introducer Set, 4 FR. Product Reorder Number: MPIS-401-10.0-SC-NT
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·November 25, 2002
COOK Stiffened Micropuncture Introducer Set, 4 FR. Product Reorder Number: MPIS-401-10.0-SC
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·November 25, 2002
Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lots ME07 & MF12, 510(k) K052185 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.
FDA Recall
Terminated
·Terumo Medical Corporation·Product code DYB·June 24, 2010
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DYB·June 30, 2021
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Recall
Terminated
·Oscor, Inc.·Product code DYB·October 5, 2016
OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Recall
Terminated
·Oscor, Inc.·Product code DYB·October 5, 2016
Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices
FDA Recall
Terminated
·Cook Inc.·Product code DYB·February 1, 2017
Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices
FDA Recall
Terminated
·Cook Inc.·Product code DYB·February 1, 2017
PINNACLE Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM Sheath PINNACLE TIF TIP" Introducer Sheath PINNACLE R/O II Radiopaque Marker Introducer Sheath
FDA Recall
Terminated
·Terumo Medical Corporation·Product code DYB·March 16, 2016