CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report
Excor Pediatric Ventricular Assist Device recalled by Berlin Heart
Berlin Heart is recalling Excor Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves, distributed nationwide in the US. The recall was initiated on 24 Apr 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2320-2026
- FDA event ID
- 98797
- Recalling firm
- Berlin Heart, Berlin, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Apr 2026
- FDA classified
- 5 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 24 Apr 2026 | Recall initiated by company | |
| 5 Jun 2026 | Classified by FDA | +42 days |
| 17 Jun 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Where it was distributed
US Nationwide distribution in the states of MA, SC.
Questions about this recall
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.
Which lots are affected?
REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254
Where was it sold?
US Nationwide distribution in the states of MA, SC.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Berlin Heart
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Excor Pediatric Ventricular Assist Device Blood Pumps recalled | Berlin Heart | Other | 16 states |
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