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Open, Classified

Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X, SLC2520X, SLC2525X, SLC2530X, SLC27512X, SLC27515X, SLC27520X, SLC3010X, SLC3012X, SLC3015X, SLC3020X, SLC3025X, SLC3030X, SLC3506X, SLC3510X, SLC3512X, SLC3515X, SLC3520X, SLC3530X, SLC4010X, SLC4012X, SLC4015X, SLC4020X, SLC4025X, SLC4030X (OUS DISTRIBUTION ONLY)

FDA Recall Z-0123-2020 · Posted None

Recalling FirmMedtronic Vascular Galway DBA Medtronic Ireland
Recall StatusOpen, Classified
Product CodeLOX
Date Initiated2019-09-03
Product Quantity98675 units

Reason for Recall

Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.

Firm Action

Medtronic notified it consignees by letter beginning on 09/03/2019. The firm requested the return of the affected product.

Root Cause

Under Investigation by firm

Distribution Pattern

worldwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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