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Catheter, Coronary, Atherectomy

FDA product code MCX · Class 3 · Unknown

76
Registered devices
11,823
Adverse events
14
Recalls
0
510(k) clearances

Devices with this code

ViperWire — Cardiovascular Systems, Inc.Viperslide — Cardiovascular Systems, Inc.RotaLink™ Burr — BOSTON SCIENTIFIC CORPORATIONRotaWire™ and wireClip™ Torquer — BOSTON SCIENTIFIC CORPORATIONAngioJet® Distaflex™ — BOSTON SCIENTIFIC CORPORATIONAngioJet® Ultra 5000A — BOSTON SCIENTIFIC CORPORATIONDiamondback Coronary — Cardiovascular Systems, Inc.RotaLink™ Plus — BOSTON SCIENTIFIC CORPORATIONDiamondback Coronary — Cardiovascular Systems, Inc.Rotablator™ Rotational Atherectomy System Console Kit — BOSTON SCIENTIFIC CORPORATIONROTAPRO™ — BOSTON SCIENTIFIC CORPORATIONRotablator™ Rotational Atherectomy System Console Kit — BOSTON SCIENTIFIC CORPORATIONROTAPRO™ — BOSTON SCIENTIFIC CORPORATIONROTAPRO™ — BOSTON SCIENTIFIC CORPORATIONDiamondback Coronary — Cardiovascular Systems, Inc.RotaLink™ Advancer — BOSTON SCIENTIFIC CORPORATIONROTAPRO™ — BOSTON SCIENTIFIC CORPORATIONRotaLink™ Burr — BOSTON SCIENTIFIC CORPORATIONRotaLink™ Plus — BOSTON SCIENTIFIC CORPORATIONROTAPRO™ — BOSTON SCIENTIFIC CORPORATIONROTAPRO™ — BOSTON SCIENTIFIC CORPORATIONROTAPRO™ — BOSTON SCIENTIFIC CORPORATIONROTAPRO™ — BOSTON SCIENTIFIC CORPORATIONROTAPRO™ — BOSTON SCIENTIFIC CORPORATION

Recent recalls

DateFirmReason
2022-03-08Boston Scientific CorporationPouch seals may be open, compromising sterility.
2022-03-08Boston Scientific CorporationPouch seals may be open, compromising sterility.
2021-11-08Boston Scientific CorporationManufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformi
2019-11-08Boston Scientific CorporationMissing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.
2018-04-13Cardiovascular Systems IncThe pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
2017-04-14Cardiovascular Systems IncCardiovascular Systems, Inc. (CSI). has initiated a recall to remove 1,396 7-10014 Saline Infusion Pumps (SIP) which were distributed by CSI between 07 April 20
2017-01-31Boston Scientific CorporationBoston Scientific has received field reports regarding the AngioJet Ultra 5000 A Console foot switch sticking during use resulting in an undesired continued ope
2015-10-09Boston Scientific CorporationBoston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction wit
2015-10-09Boston Scientific CorporationBoston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction wit
2015-03-04Cardiovascular Systems, Inc.The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in co

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.