510(k) Report

FDA applicant

Berlin Heart, Inc.

The Woodlands1 decision2017–20172 recalls

FDA records 1 decision for Berlin Heart, Inc. (The Woodlands) in 2017: 1 original PMA approval. All are in product code DSQ (Ventricular (Assist) Bypass). 2 recalls are linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Berlin Heart, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2026

2018: 1, 1 Class I2026 (partial year): 1
2017high 1 (2018) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Berlin Heart, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DSQVentricular (Assist) Bypass1decision

What has FDA decided for it lately?

  • P160035EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc. · 20171 Class I recall

The one decision as Berlin Heart, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • P160035EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF…Apr 24, 2026Class II
  • P160035EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood…May 18, 2018Class I