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ROTAPRO™

BOSTON SCIENTIFIC CORPORATION · Model H74939309010 · UDI-DI 08714729975076

MCX Prescription
0
510(k) clearances
11,823
Adverse events (874 deaths)
14
Recalls
24
Facilities

Description

Rotational Atherectomy System

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 nonconformity.
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 2015 and 04 April 2017
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 operation of the device
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 with the Rotablator Rot
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 with the Rotablator Rot
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 contact with during cl

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.