Exact FDA event identifier

Event 98797

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

Open FDA event record

Event summary

Timeline bucket: April 24, 2026
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: BERLIN HEART GMBH

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

EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01

Z-2320-2026

Recall number: Z-2320-2026
Initiated: April 24, 2026
Classification: Class II
Status: Ongoing
Recalling firm: BERLIN HEART GMBH
Quantity: 3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.

Code information

REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254

Distribution pattern

US Nationwide distribution in the states of MA, SC.