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HomeTHROMBOLEX, INC. › BASHIR™ S-B .035 Endovascular Catheter

BASHIR™ S-B .035 Endovascular Catheter

THROMBOLEX, INC. · Model 8101 · UDI-DI 00850005115083

QEYKRA Prescription
1
510(k) clearances
28
Adverse events (4 deaths)
4
Recalls
23
Facilities

Description

Bashir™ .035 S-B Endovascular Catheter 8Fr, 10.0cm basket

Recalls

DateFirmReason
2023-11-06Merit Medical Systems, Inc.The sterility of microcatheter and infusion system devices cannot be guaranteed.
2022-10-13Boston Scientific CorporationConsoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
2022-05-25Boston Scientific CorporationProduct may be mislabeled.
2022-05-25Boston Scientific CorporationProduct may be mislabeled.

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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.