Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 126 of 138
Smiths Medical ASD, Inc.
Class I Terminated
H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
Reason: The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a s...
Z-2538-2014 September 3, 2014 Keene, NH
Smiths Medical ASD, Inc.
Class I Terminated
H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
Reason: The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a s...
Z-2537-2014 September 3, 2014 Keene, NH
Cordis Corporation
Class II Terminated
Cordis EMPIRA NC RX PTCA Dilatation Catheter
Reason: The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force ...
Z-2556-2014 September 3, 2014 Miami Lakes, FL
Cordis Corporation
Class II Terminated
Cordis EMPIRA RX PTCA Dilatation Catheter
Reason: The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force ...
Z-2557-2014 September 3, 2014 Miami Lakes, FL
Cook Inc.
Class I Terminated
CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box. The CloverSnare 4-Loop Vascular Retriever is intende...
Reason: This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire.
Z-2243-2014 September 3, 2014 Bloomington, IN
Smiths Medical ASD, Inc.
Class I Terminated
4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
Reason: The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a s...
Z-2536-2014 September 3, 2014 Keene, NH
Smiths Medical ASD, Inc.
Class I Terminated
H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit
Reason: The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a s...
Z-2539-2014 September 3, 2014 Keene, NH
Smiths Medical ASD, Inc.
Class I Terminated
H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
Reason: The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a s...
Z-2540-2014 September 3, 2014 Keene, NH
Codman & Shurtleff, Inc.
Class II Terminated
Codman Certas - In line Valve with Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8803 The Codman Certas Programmable valve is an implantable device that provides constant intrave...
Reason: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
Z-2187-2014 August 20, 2014 Raynham, MA
Codman & Shurtleff, Inc.
Class II Terminated
Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 The Codman Certas Programmable valve is an implantable device that provides constant intrave...
Reason: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
Z-2189-2014 August 20, 2014 Raynham, MA
Codman & Shurtleff, Inc.
Class II Terminated
Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure an...
Reason: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
Z-2185-2014 August 20, 2014 Raynham, MA
Codman & Shurtleff, Inc.
Class II Terminated
Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8807 The Codman Certas Programmable valve is an implantable device that prov...
Reason: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
Z-2191-2014 August 20, 2014 Raynham, MA
Codman & Shurtleff, Inc.
Class II Terminated
Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pr...
Reason: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
Z-2186-2014 August 20, 2014 Raynham, MA
Codman & Shurtleff, Inc.
Class II Terminated
Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessories; Product Code: 82-8806 The Codman Certas Programmable valve is an implantable device that provides constant intra...
Reason: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
Z-2190-2014 August 20, 2014 Raynham, MA
Medtronic Neuromodulation
Class II Terminated
Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784. The Ascenda Intrathecal Catheter is part of an infusion system...
Reason: Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which are used with the implantable SynchroMed drug infusion pump. This recall is being...
Z-2172-2014 August 20, 2014 Minneapolis, MN
Teleflex Medical
Class III Terminated
RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.
Reason: Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date is correct, however the expiration date incorrectly indicates that the product is ...
Z-2154-2014 August 13, 2014 Durham, NC
Perouse Medical
Class II Terminated
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
Reason: Perouse Medical in France initiated a voluntary recall of certain batches of Perouse FLAMINGO Inflations Devices due to a potential water-tightness default. The potential default c...
Z-2089-2014 July 30, 2014 Irigny
Terumo Cardiovascular Systems Corporation
Class II Terminated
CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
Reason: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
Z-2106-2014 July 30, 2014 Ann Arbor, MI
Integra LifeSciences Corp.
Class II Terminated
Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L
Reason: Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment.
Z-2072-2014 July 23, 2014 Plainsboro, NJ
RGI Medical Manufacturing, Inc.
Class II Terminated
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
Reason: Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.
Z-1996-2014 July 16, 2014 Gainesville, FL
Medtronic Neurosurgery
Class I Terminated
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) a...
Reason: Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems...
Z-1922-2014 July 9, 2014 Goleta, CA
Medtronic Neurosurgery
Class I Terminated
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) a...
Reason: Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems...
Z-1923-2014 July 9, 2014 Goleta, CA
Medtronic Neurosurgery
Class I Terminated
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and ot...
Reason: Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems...
Z-1924-2014 July 9, 2014 Goleta, CA
Vascular Solutions, Inc.
Class I Terminated
Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast m...
Reason: The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the...
Z-1981-2014 July 9, 2014 Maple Grove, MN
Nitinol Devices and Components, Inc.
Class I Terminated
HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by...
Reason: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Z-1820-2014 July 2, 2014 Fremont, CA