Home › Device types › MJN
Catheter, Intravascular Occluding, Temporary
FDA product code MJN · Class 2 · Cardiovascular
405
Registered devices
2,367
Adverse events
21
Recalls
90
510(k) clearances
Devices with this code
LMI BILUMEN IRRIGATION (DISTAL) ARTERIAL EMBOLECTOMY CATHETER — LUCAS MEDICAL INCHyperFormTM — Micro Therapeutics, Inc.ASCENT — Medos International SàrlREBOA Catheter — NUMED, INC.Balloon Catheter — Microvention, Inc.REBOA Catheter — NUMED, INC.TwinFlo™ Catheter — Thermopeutix, Inc.PTS-X™ — B BRAUN INTERVENTIONAL SYSTEMS, INCHyperFormTM — Micro Therapeutics, Inc.CAROTID ENDARTERECTOMY SHUNT — LUCAS MEDICAL INCPTS-X™ — B BRAUN INTERVENTIONAL SYSTEMS, INCTRANSFORM — Stryker CorporationBalloon Catheter — Microvention, Inc.Bridge Occlusion Balloon — Spectranetics CorporationREBOA Catheter — NUMED, INC.Balloon Catheter — Microvention, Inc.RenovoCath — Renovorx, Inc.Flexcel Carotid Shunt — Lemaitre Vascular, Inc.LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CATHETER — LUCAS MEDICAL INCTRANSFORM — Stryker CorporationLMI BILUMEN IRRIGATION (PROXIMAL) ARTERIAL EMBOLECTOMY CATHETER — LUCAS MEDICAL INCREBOA Catheter — NUMED, INC.TAPAS® Catheter — Thermopeutix, Inc.HyperGlideTM — Micro Therapeutics, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-07-12 | W. L. Gore & Associates Inc. | Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or |
| 2020-10-29 | Prytime Medical Devices, Inc. | There is a potential that catheters may have incorrectly marked balloon and arterial lines. This could result in a procedure delay or injury to the patient |
| 2020-03-31 | Spectranetics Corporation | There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. All users, such as those performing lead extr |
| 2019-07-24 | LeMaitre Vascular, Inc. | incorrect device size being listed on the impacted device packaging |
| 2018-10-01 | LeMaitre Vascular, Inc. | Pouches from this lot are not sealed compromising the sterility |
| 2017-08-07 | Spectranetics Corporation | Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment. |
| 2016-10-31 | Spectranetics Corporation | Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion |
| 2016-10-06 | AccessClosure, Inc., A Cardinal Health Company | AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device because it was made aware from customers that the device may be |
| 2015-11-25 | RenovoRx, Inc. | Incorrect version of Instructions for Use were shipped to two US customers. |
| 2013-11-04 | Stryker Neurovascular | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of A |
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