FDA Class II Recall: EXCOR Pediatric Ventricular Assist Device (VAD) System Blood… by BERLIN HEART GMBH — Recall Details

Key facts

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is BERLIN HEART GMBH and the affected product is described in FDA's record as: EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01. FDA's stated reason for the recall is: Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.. The recall is tracked under FDA recall number Z-2320-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01 -- and the recall number Z-2320-2026. If it matches, stop using or distributing it and contact BERLIN HEART GMBH or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

BERLIN HEART GMBH’s FDA history

Argus HQ has recorded 1 total FDA action tied to BERLIN HEART GMBH: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01) and recall number Z-2320-2026, then follow BERLIN HEART GMBH's recall instructions.

Has BERLIN HEART GMBH had other FDA recalls or enforcement actions?

This is the only FDA action Argus HQ has on file for BERLIN HEART GMBH so far. Argus ingests new FDA enforcement records daily.

What is the FDA recall number for this event?

FDA recall number Z-2320-2026.

Related enforcement actions