THORATEC® PVAD™, VENTRICULAR ASSIST DEVICE - BLOOD PUMP 14086-2550-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00813024012009), received between Feb 24, 2019 and Feb 3, 2023 — classified as 6 deaths, 5 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSPLANT. THE CUSTOMER REPORTED THAT NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16297221 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE CAUSE OF DEATH IS UNKNOWN. WHETHER THE OUTCOME WAS DEVICE OR THERAPY RELATED WAS NOT PROVIDED BY THE CUSTOMER. AN AUTOPSY WAS NOT PERFORMED. THE PUMP WAS NOT EXPLANTED AND WILL NOT RETURN FOR EVALUATION. THE CUSTOMER REPORTED THAT NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16296115 ↗
• DeathFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE CUSTOMER REPORTED THAT NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16295763 ↗
• DeathFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE CAUSE OF DEATH IS UNKNOWN. WHETHER THE OUTCOME WAS DEVICE OR THERAPY RELATED WAS NOT PROVIDED BY THE CUSTOMER. AN AUTOPSY WAS NOT PERFORMED. THE PUMP WAS NOT EXPLANTED AND WILL NOT RETURN FOR EVALUATION. THE CUSTOMER REPORTED THAT NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16295563 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE CAUSE OF DEATH IS UNKNOWN. WHETHER THE OUTCOME WAS DEVICE OR THERAPY RELATED WAS NOT PROVIDED BY THE CUSTOMER. AN AUTOPSY WAS NOT PERFORMED. THE PUMP WAS NOT EXPLANTED, AND THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE CUSTOMER REPORTED THAT NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16295384 ↗
• DeathFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE CAUSE OF DEATH IS UNKNOWN. WHETHER THE OUTCOME WAS DEVICE OR THERAPY RELATED WAS NOT PROVIDED BY THE CUSTOMER. AN AUTOPSY WAS NOT PERFORMED. THE PUMP WAS NOT EXPLANTED, AND THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE CUSTOMER REPORTED THAT NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16295332 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSPLANT. THE CUSTOMER REPORTED THAT NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16294647 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSPLANT. THE CUSTOMER REPORTED THAT NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16294633 ↗
• DeathSep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2017. IT WAS REPORTED THAT PATIENT EXPIRED FROM A HEMORRHAGIC STROKE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; Stroke/CVA

  MAUDE report 9011821 ↗
• DeathFeb 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS SUPPORTED WITH TWO PARACORPOREAL VENTRICULAR ASSIST DEVICES (PVADS) FOR BIVENTRICULAR SUPPORT ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6)2014. THE CAUSE OF EXPIRATION WAS LONG STANDING PSEUDOMONAS DRIVELINE INFECTION WITH BACTEREMIA. NO AUTOPSY WAS PERFORMED AND THE DEVICES WERE NOT EXPLANTED. PVAD SERIAL NUMBER (B)(4) WAS IMPLANTED FOR LEFT VENTRICULAR SUPPORT AND PVAD SERIAL NUMBER (B)(4) WAS IMPLANTED FOR RIGHT VENTRICULAR SUPPORT.

  Patient problems: Death; Unspecified Infection

  MAUDE report 8364875 ↗
• DeathFeb 24, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS SUPPORTED WITH TWO PARACORPOREAL VENTRICULAR ASSIST DEVICES (PVADS) FOR BIVENTRICULAR SUPPORT ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2014. THE CAUSE OF EXPIRATION WAS LONG STANDING PSEUDOMONAS DRIVELINE INFECTION WITH BACTEREMIA. NO AUTOPSY WAS PERFORMED AND THE DEVICES WERE NOT EXPLANTED. PVAD SERIAL NUMBER (B)(4) WAS IMPLANTED FOR LEFT VENTRICULAR SUPPORT AND PVAD SERIAL NUMBER (B)(4) WAS IMPLANTED FOR RIGHT VENTRICULAR SUPPORT.

  Patient problems: Death; Unspecified Infection

  MAUDE report 8364867 ↗