FDA Medical devices recall ·
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU… recall
- Recall number
- Z-2320-2026
- Date
- (initiated April 24, 2026)
- Company / brand
- Berlin Heart Gmbh
Wiesenweg 10, Berlin, N/A, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Why was it recalled?
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254
Distribution
US Nationwide distribution in the states of MA, SC.
States: Massachusetts South Carolina
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2320-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.