EXCOR Pediatric VAD System Blood Pump Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Berlin Heart GmbH is recalling three units of EXCOR Pediatric Ventricular Assist Device System Blood Pumps due to mismatched expiration dates on packaging.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 28, 2026 and geographically references Massachusetts, South Carolina. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Berlin Heart GmbH initiated a voluntary recall of certain EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pumps because the blood pump inner package expiration date does not match the outer package expiration date, which may lead to delays in surgical procedures.
Which Products Are Affected
The recall affects 3 units of the EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves distributed in the United States. Affected products include:
- 10 ml, REF: P10P-001 (serial numbers 2230714, 2230709; UDI-DI 04260090040102)
- 30 ml, REF: P30P-001x01 (serial number 2230254; UDI-DI 04260090040126)
Distribution was limited to Massachusetts and South Carolina. The recall number is Z-2320-2026 and it is classified as Class II.
What You Should Do
Consumers and healthcare facilities should verify product expiration dates and follow any instructions provided by the recalling firm regarding affected units.
Why This Matters
The mismatch in expiration dates on three units could cause delays during surgical procedures involving the EXCOR Pediatric VAD System.
Source
FDA recall Z-2320-2026; Berlin Heart GmbH, Berlin, Germany.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,190 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 28, 2026.
Frequently Asked Questions
Common questions about this FDA recall.