Embol-X Glide Access Device/Aortic Cannula With Flange
The EMBOL-X Glide Access Device is an aortic cannula that returns oxygenated blood from the bypass oxygenator to the patient during cardiopulmonary bypass. It provides perfusion of the…
The EMBOL-X Glide Access Device is an aortic cannula that returns oxygenated blood from the bypass oxygenator to the patient during cardiopulmonary bypass. It provides perfusion of the ascending aorta during the surgical procedure.
The polymer tube is reinforced with stainless steel wire enclosed within its wall to reduce kinking. An access port allows optional insertion of a compatible EMBOL-X filter or other compatible intravascular device.
Listed Item
Embol-X Glide Access Device / Aortic Cannula With Flange
Access and Supply
The access feature permits hemostatic introduction and removal of compatible devices while the cannula is in use. The cannula is supplied sterile and nonpyrogenic and is intended for single use.
3manufacturers in China registered for this device type
1catalogue number
19510(k) clearances naming this product code
34recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
Record
| Listed by | Edwards Lifesciences Technology Sarl, United States |
|---|---|
| FDA product code | DWF |
| Device type | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4210 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K102420 |
| Record published | 2016-08-31 |
| Record revised | 2024-06-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store in a cool, dry, dark place until ready for use. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EXGF24D | 24 Fr. (8 mm) x 11″ (28 cm) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Medtronic, Inc. | 5,237 |
| DLP™ | Medtronic, Inc. | 804 |
| Bio-Medicus™ | Medtronic, Inc. | 223 |
| Pemco Inc | Pemco, Inc. | 137 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Maquet Cardiopulmonary GmbH | 135 |
| Venous cardiopulmonary bypass cannula | LivaNova USA, Inc. | 97 |
| Eopa™ | Medtronic, Inc. | 87 |
| Surge Cardiovascular | MED Michigan Holdings LLC | 80 |
| Arterial cardiopulmonary bypass cannula | LivaNova USA, Inc. | 79 |
| MC2™ | Medtronic, Inc. | 66 |
| Select Series® | Medtronic, Inc. | 63 |
| Edwards Lifesciences Aortic Perfusion Cannula | Edwards Lifesciences Technology Sarl | 52 |
Showing 12 of 372. All products under Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233895 | 2024-02-05 |
| K200499 | 2020-03-29 |
| K200358 | 2020-03-13 |
| K140208 | 2014-03-05 |
| K123303 | 2013-03-22 |
| K123298 | 2013-03-15 |
| K123370 | 2013-03-13 |
| K123187 | 2013-02-22 |
| K113459 | 2012-06-29 |
| K120780 | 2012-06-27 |
| K113411 | 2012-06-11 |
| K120072 | 2012-05-08 |
| K102420 | 2010-10-26 |
| K093730 | 2010-01-14 |
| K092509 | 2009-10-08 |
| K033463 | 2004-07-28 |
| K033464 | 2004-06-22 |
| K002578 | 2002-04-11 |
| K001565 | 2000-08-10 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Edwards Lifesciences Technology Sarl | 510(k) number | 2013-09-16 | Class I | Nonconforming Material/Component | Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip. | 12,034 | 2017-03-10 |
Recalls
15 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-11-27 | Class II | Other | If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during extracorporeal membrane oxygenation [ECMO]) there is a risk that separation of the cannula from its connector can occur; which can result in sig | 27168 | 2024-05-28 |
| 2019-10-22 | Class II | Under Investigation by firm | Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circuit during cardiopulmonary bypass which could result in significant blood loss. | 62,431 units | 2022-06-29 |
| 2015-11-04 | Class II | Employee error | Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size is 1/2 inch | 8,915 units | 2017-02-10 |
| 2015-03-23 | Class II | Process change control | Edwards Lifesciences is recalling Fem-Flex II Pediatric Femoral Arterial Cannula sizes 8, 10, 12 French because of the potential of tissue damage caused by a protruding wire located at the tip of the cannula. | 5125 units | 2017-04-17 |
| 2014-10-08 | Class II | Device Design | Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for disruption of the white plastic coating on the stylet. | 157,305 | 2016-12-15 |
| 2014-04-09 | Class II | Nonconforming Material/Component | Potential for separation of dilator tips. | 28,885 | 2016-12-28 |
| 2014-04-09 | Class II | Nonconforming Material/Component | Potential for separation of dilator tips. | 13,115 | 2016-12-28 |
| 2013-08-26 | Class II | Process control | Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation. | 80 units | 2017-02-22 |
| 2013-08-26 | Class II | Process control | Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation. | 140 units | 2017-02-22 |
| 2013-07-30 | Class II | Process control | Edwards Lifesciences is recalling certain lots of the Anastaflo intravascular Shunt due to concerns of excessive adhesive on the shunt body that may interfere with suturing of by-pass grafts. | 29,618 units | 2014-10-14 |
| 2013-07-16 | Class II | Nonconforming Material/Component | Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an incorrect component. This component can create a performance problem with the IntraClude IntraAortic Occlusion device. | 855 | 2016-11-30 |
| 2013-06-19 | Class II | Component design/selection | Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand. | S099: 171,587 units and S099B: 505,107 units | 2014-11-04 |
| 2013-03-14 | Class II | Packaging process control | Two unsealed pouches were found at an Edwards’ distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach. | 379 units | 2016-03-08 |
| 2013-01-25 | Class II | Device Design | 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 is kitted with the catheter. | 807 | 2017-02-16 |
| 2012-06-06 | Class II | Process control | Edwards is recalling Suction Wand models SPC2081 and S033 because the plastic tip attached to the metal suction wand may become detached during routine use. | 1524 units | 2012-09-10 |
| 2011-06-15 | Not classified | Employee error | Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters. | 97 units | 2012-06-01 |
| 2011-06-15 | Not classified | Employee error | Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters. | 2798 units | 2012-06-01 |
| 2011-01-21 | Not classified | Other | Bonding of the tip to the aortic cannula tubing may decline over time and may contribute to a drop in bond strength. Possible tip separation. | 20 | 2011-05-13 |
| 2010-12-03 | Not classified | Device Design | Defective product may result in the silicone valve becoming dislodged from the introducer which can result in injury. | 90 kits | 2011-10-27 |
| 2010-12-03 | Not classified | Device Design | Defective product may result in the silicone valve becoming dislodged from the introducer which can result in injury. | 3,427 kits | 2011-10-27 |
| 2008-07-14 | Not classified | Process control | Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow. | 707 units | 2008-12-23 |
| 2008-07-14 | Not classified | Process control | Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow. | 690 units | 2008-12-23 |
| 2008-07-14 | Not classified | Process control | Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow. | 90 units | 2008-12-23 |
| 2008-02-25 | Not classified | Process control | Femoral Venous Cannula was color coded as an arterial cannula. This problem could result in a minor delay in the procedure. In the worst case, this product could be connected incorrectly during bypass, which would result in a more significa | 10 units | 2008-09-16 |
| 2008-02-25 | Not classified | Process control | Femoral Venous Cannula was color coded as an arterial cannula. This problem could result in a minor delay in the procedure. In the worst case, this product could be connected incorrectly during bypass, which would result in a more significa | 25 units | 2008-09-16 |
| 2006-04-18 | Not classified | Other | Due to potential embrittlement of the overmolded plastic portion of the metal tip which may crack or separate during use. | 30 units (Domestic), 30 units (Foreign) | 2008-06-11 |
| 2006-04-18 | Not classified | Other | Due to potential embrittlement of the plastic tip which may crack or separate during use. | 50 units (Domestic) | 2008-06-11 |
| 2006-04-18 | Not classified | Other | Due to potential embrittlement of the plastic tip which may crack or separate during use. | 240 units (Foreign) | 2008-06-11 |
| 2006-04-18 | Not classified | Other | Due to potential embrittlement of the plastic tip which may crack or separate during use. | 190 units (Domestic), 800 units (Foreign). | 2008-06-11 |
| 2006-04-18 | Not classified | Other | Due to potential embrittlement of the plastic tip which may crack or separate during use. | 50 units (Foreign) | 2008-06-11 |
| 2006-04-18 | Not classified | Other | Due to potential embrittlement of the overmolded plastic portion of the metal tip which may crack or separate during use. | 26 units (Domestic), 420 units (Foreign) | 2008-06-11 |
| 2006-04-18 | Not classified | Other | Due to potential embrittlement of the plastic tip which may crack or separate during use. | 320 units (Domestic) | 2008-06-11 |
| 2004-11-19 | Not classified | Other | Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery. | 396 units | 2005-01-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.