Exact FDA event identifier

Event 71169

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: May 05, 2015
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Edwards Lifesciences, LLC

Dossier provenance

Source snapshots represented here

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.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

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

Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.

Z-1700-2015

Recall number: Z-1700-2015
Initiated: May 05, 2015
Classification: Class II
Status: Terminated
Recalling firm: Edwards Lifesciences, LLC
Quantity: 978

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The product failed to meet the internal established statistical test requirement for heparin activity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product failed to meet the internal established statistical test requirement for heparin activity.

Code information

lot number 59860969.

Distribution pattern

Worldwide distribution US nationwide, Canada and Europe (IC, BE, IT, GB, FR, DK, CZ, DE, AT, ES, IE, NO, PL)