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 1
Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves, when a simple preimplantation test is desired to verify that the valve conforms to labeled product specifications.
Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer carton had expiration dates that were incorrect. The date on the outer carton is later than the expiration date for one or more of the individually packaged sterile components in the kit.
These labels are deterministic app interpretations, not FDA categories.
Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer carton had expiration dates that were incorrect. The date on the outer carton is later than the expiration date for one or more of the individually packaged sterile components in the kit.
