Pediatric Ventricular Assist Device Blood Pumps Recalled for Potential Membrane Disruption
BERLIN HEART GMBH recalls EXCOR Pediatric Ventricular Assist Device Blood Pumps due to potential disruption in triple-layer membranes. The 335 affected units were distributed to multiple US states and Canada.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, the highest severity classification for medical devices, indicating a serious hazard to health. The affected device is critical life-support equipment for pediatric patients with heart failure.
Plain-English summary
BERLIN HEART GMBH is recalling specific models of EXCOR Pediatric Ventricular Assist Device Blood Pumps (Models P10P-001, P15P-001, P25P-001x01, P30P-001x01, P50P-001, and P60P-001) due to a potential for disruption in one or more of the triple-layer membranes. These membranes are critical to proper device function.
The recall affects 335 units that were distributed to medical facilities in multiple US states (Massachusetts, Texas, Wisconsin, California, South Carolina, Florida, Colorado, New York, Pennsylvania, North Carolina, Utah, Georgia, Minnesota, Ohio, Arizona, and Alabama) as well as Canada. The recall was originally initiated in 2018 and is being retrospectively reported.
Healthcare providers and patients using affected devices should contact BERLIN HEART GMBH or the FDA for information and guidance regarding their specific units. The device model and serial number can be used to determine if a particular unit is affected by this recall.
The recalled product
- Product
- 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…
- Manufacturer
- BERLIN HEART GMBH
- Hazard
- Affected units
- 335
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- P15P-001 (UDI-DI: 04260090040157) - Serial Numbers:
Distribution
Related recalls
Same manufacturer · BERLIN HEART GMBH
See all →- ModerateEXCOR pediatric blood pump valves carry mismatched inner package expiration dates
FDA (Devices) · 2026-06-17
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateEXCOR pediatric blood pump valves carry mismatched inner package expiration dates
FDA (Devices) · 2026-06-17
- HighBlood Pump Recalled for Potential Fluid Leakage During Clinical Use
FDA (Devices) · 2025-03-19
- SevereMaquet Cardiovascular Recalls QUADROX-i Neonatal Membrane Oxygenators
FDA (Devices) · 2018-12-05
- SevereMaquet QUADROX-i Neonatal Membrane Oxygenator Recalled for Blood Leakage Risk
FDA (Devices) · 2018-12-05
- SevereVentlab V*Care Infant Resuscitator Recalled for Potential Volume Leakage
FDA (Devices) · 2012-11-07
- HighParks Medical Electronics Recalls Vascular Blood Flow Machines Due to Connection Error
FDA (Devices) · 2012-12-05