Thoratec PVAD, Cannula Tunneler 20099-2575-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00813024013105), received between Feb 3, 2023 and Feb 5, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 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 16301991 ↗
• InjuryFeb 5, 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 16301989 ↗
• 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. WHETHER THE OUTCOME WAS DEVICE OR THERAPY RELATED WAS NOT PROVIDED BY THE CUSTOMER. THE DEVICE WILL NOT RETURN FOR EVALUATION. THE CUSTOMER REPORTED THAT NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16298347 ↗
• 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. WHETHER THE OUTCOME WAS DEVICE OR THERAPY RELATED WAS NOT PROVIDED BY THE CUSTOMER. THE DEVICE WILL NOT RETURN FOR EVALUATION. THE CUSTOMER REPORTED THAT NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16298216 ↗