Facility

BERLIN HEART, INC.

2 recall(s) on record — most severe on record: Class I.

Key facts

2recalls · worst Class I

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3008454189
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	9391 Grogan's Mill Road The Woodlands, TX, US 77380
Registration status	Active · expires 2026
Parent company	Berlin Heart, Inc. (owner-operator 10039498)
Brand names	EXCOR® Pediatric Ventricular Assist Device

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Ventricular (Assist) Bypass
Product code DSQ (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class IIOngoing2026-04-24
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Class ITerminated2018-05-18
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.

FDA inspections (1)

NAI2016-12-09
No Action Indicated · Bioresearch Monitoring

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Berlin Heart, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “BERLIN HEART, INC. (FEI 3008454189) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008454189-berlin-heart-inc/

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