Exact FDA event identifier

Event 96015

3 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: December 12, 2024
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Medtronic Perfusion Systems

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

3 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 3

DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)

Z-0984-2025

Recall number: Z-0984-2025
Initiated: December 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Medtronic Perfusion Systems
Quantity: 745 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Incorrect labeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

Code information

Model 77008 UDI-DI: 20763000091105, Lot Numbers: 2024010723, 202404C049; Model 77014 UDI-DI: 20763000091136, Lot Number: 2023121097

Distribution pattern

Worldwide - US Nationwide distribution.

device · product 2 of 3

EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)

Z-0985-2025

Recall number: Z-0985-2025
Initiated: December 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Medtronic Perfusion Systems
Quantity: 930 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Incorrect labeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

Code information

Model 77418 UDI-DI: 20763000135618, Lot Numbers: 2022041038; Model 77422 UDI-DI: 20643169485970, Lot Number: 2023020934

Distribution pattern

Worldwide - US Nationwide distribution.

device · product 3 of 3

Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)

Z-0986-2025

Recall number: Z-0986-2025
Initiated: December 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Medtronic Perfusion Systems
Quantity: 440 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Incorrect labeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

Code information

Model 72422 UDI-DI: 20643169485970, Lot Numbers: 2023071075, 202309C075

Distribution pattern

Worldwide - US Nationwide distribution.