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Protrieve Sheath

Inari Medical, Inc. · Model 60-101 · UDI-DI 00850291007222

QEWKRA Prescription
10
510(k) clearances
1,318
Adverse events (128 deaths)
10
Recalls
72
Facilities

Description

Protrieve™ Sheath (Sheath)

Recalls

DateFirmReason
2025-04-08Inari Medical - Oak CanyonThrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally incr
2024-07-19Inari Medical - Oak CanyonThrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected
2024-05-01Mermaid Medical A/SInternal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
2022-01-11TELEFLEX MEDICAL INCThe firm received reports indicating PTD tip separation during use.
2022-01-11TELEFLEX MEDICAL INCThe firm received reports indicating PTD tip separation during use.
2022-01-11TELEFLEX MEDICAL INCThe firm received reports indicating PTD tip separation during use.
2022-01-11TELEFLEX MEDICAL INCThe firm received reports indicating PTD tip separation during use.
2022-01-11TELEFLEX MEDICAL INCThe firm received reports indicating PTD tip separation during use.
2022-01-11TELEFLEX MEDICAL INCThe firm received reports indicating PTD tip separation during use.
2022-01-11TELEFLEX MEDICAL INCThe firm received reports indicating PTD tip separation during use.

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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.