International safety notice
BioPath™, ELUVIA™, IN.PACT Admiral™, IN.PACT Pacific™, LEGFLOW OTW, LEGFLOW RX, iVascular Luminor, Lutonix®, Passeo-18 Lux, Ranger™, Ranger™ SL, SeQuent® Please OTW, Stellarex, Zilver® PTX®
Spain / AEMPS · ESP · Jul 10, 2020
Key facts
| Title | BioPath™, ELUVIA™, IN.PACT Admiral™, IN.PACT Pacific™, LEGFLOW OTW, LEGFLOW RX, iVascular Luminor, Lutonix®, Passeo-18 Lux, Ranger™, Ranger™ SL, SeQuent® Please OTW, Stellarex, Zilver® PTX® |
|---|---|
| Regulator | Spain / AEMPS |
| Country | ESP |
| Brand | BioPath™, ELUVIA™, IN.PACT Admiral™, IN.PACT Pacific™, LEGFLOW OTW, LEGFLOW RX, iVascular Luminor, Lutonix®, Passeo-18 Lux, Ranger™, Ranger™ SL, SeQuent® Please OTW, Stellarex, Zilver® PTX® |
| Manufacturer | B. Braun Melsungen AG, Alemania; Biosensors Europe SA, Suiza; Biotronik AG, Irlanda; Boston Scientific International S.A., EEUU; CARDIONOVUM GmbH, Alemania; Cook Ireland LTD, Irlanda; Lutonix, Inc, EEUU; LVD Biotech SL, España; Medtronic, Inc, EEUU; Spect |
| Models | DISMINUCI6N, 14153, 10.23736, 53227, 28022, 59775-59783, PASSEO-18, COMPARACI6N, INFORMACI6N, 22.06.2020, 60283, E011245 and 6 more |
| Event type | Safety Notice |
| Date | Jul 10, 2020 |
At a glance
- No Recall
- Yes Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1