openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 2
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.
These labels are deterministic app interpretations, not FDA categories.
The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.
Code information
GTIN 00763000402396
Distribution pattern
US Nationwide distribution in the states of AZ, CA, FL, IA, IL, KS, LA, MI, MS, NC, NJ, NY, OR, SC, SD, TN, TX, and VA.
device · product 2 of 2
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.
These labels are deterministic app interpretations, not FDA categories.
The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.
Code information
GTIN 00763000402419
Distribution pattern
US Nationwide distribution in the states of AZ, CA, FL, IA, IL, KS, LA, MI, MS, NC, NJ, NY, OR, SC, SD, TN, TX, and VA.
