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NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter

NORTH EAST SCIENTIFIC INC · Model R-410-152 · UDI-DI 00850044399055

QTF Prescription
1
510(k) clearances
0
Adverse events
8
Recalls
1
Facilities

Recalls

DateFirmReason
2025-08-29Northeast Scientific Inc.Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29Northeast Scientific Inc.Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29Northeast Scientific Inc.Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29Northeast Scientific Inc.Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29Northeast Scientific Inc.Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29Northeast Scientific Inc.Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29Northeast Scientific Inc.Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29Northeast Scientific Inc.Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

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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.