Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
EXCOR Pediatric Ventricular Assist Device Blood Pumps Recalled by BERLIN HEART GMBH Due to There is a potential for a disruption in...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact BERLIN HEART GMBH directly.
Affected Products
EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was retrospectively reported.
Quantity: 335 units
Why Was This Recalled?
There is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device. Recall occurred in 2018, and was retrospectively reported.
Where Was This Sold?
This product was distributed to 16 states: AL, AZ, CA, CO, FL, GA, MA, MN, NY, NC, OH, PA, SC, TX, UT, WI
About BERLIN HEART GMBH
BERLIN HEART GMBH has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report