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
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300
Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon
These labels are deterministic app interpretations, not FDA categories.
Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon
Code information
Lot Number: 19343203 Exp.: 6/30/2018
Distribution pattern
MI, MO Foreign: Austria France Great Britain Italy Spain Sweden
device · product 2 of 2
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon
These labels are deterministic app interpretations, not FDA categories.
Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon
Code information
Lot Number: 19343209 Exp: 6/3 0/2018
Distribution pattern
MI, MO Foreign: Austria France Great Britain Italy Spain Sweden
