EXCOR® T00L-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04260090040553), received between Jun 14, 2017 and Jan 23, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Disconnection” (1 report).

2 other recalls cover devices cleared under the same FDA submission (H100004, P160035); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2023Use of Device Problem; Use of Device Problem

  THE SITE CONTACTED CLINICAL AFFAIRS TO REPORT THAT THE SURGEON ATTEMPTING TO DE-AIR THE BLOOD PUMP WHEN THE STOPCOCK AT THE END OF THE PRIMING TUBE BECAME DISLODGED FROM THE TUBING. AS A RESULT, AIR WAS ENTRAINED IN THE BLOOD PUMP. WHILE THE DE-AIRING PROCESS WAS ULTIMATELY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16229759 ↗
• MalfunctionJun 14, 2017Disconnection; Disconnection

  THE SITE CONTACTED BERLIN HEART INC. CLINICAL AFFAIRS (CA) TO REPORT THAT DURING THE IMPLANTATION OF THE LEFT EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN BVAD CONFIGURATION, THE STOP COCK DISCONNECTED FROM THE DE-AIRING TUBING. SINGLE-STEP PUMPING WAS STOPPED IMMEDIATELY AND NO AIR WAS INTRODUCED INTO THE PUMP OR THE PATIENT. THE SURGEON WAS ABLE TO RE-CONNECT THE STOP COCK TO THE TUBING AND SUCCESSFULLY PERFORM DE-AIRING OF THE BLOOD PUMP. THE PATIENT WAS IMPLANTED WITHOUT ANY ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6640253 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under H100004, P160035. One submission often covers many models, so check the product and lot details in each record.

• Z-2320-2026 · Apr 24, 2026 · Open, Classified
  EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
• Z-1618-2023 · May 18, 2018 · Terminated
  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