RegWardenFDA facility compliance records
Company

Berlin Heart, Inc.

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

Recalls by year

FDA actions on record by year2018: 1 recalls; 2026: 1 recalls201712018201920202021202220232024202512026
  • Recalls (2)

Registered facilities (1)

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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Berlin Heart, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10039498-berlin-heart-inc/

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