EchoMark LP 2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B53620001), received between Apr 9, 2021 and Apr 9, 2021 — classified as 1 death, 1 injury.

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. How this data works · Data updated Oct 13, 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.

• DeathApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEATH REPORTED TO HAVE OCCURRED IN 30 DAY POSTOPERATIVE WINDOW. CAUSE OF DEATH UNKNOWN. NO INDICATION OF IMPLANT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 11646254 ↗
• InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO WEEKS POST-OP PATIENT REPORTED PAIN AND CLEAR FLUID DRAINAGE. PAIN MEDICATION AND PROPHYLACTIC ANTIBIOTICS PRESCRIBED. ELECTIVE SURGICAL RE-EXPLORATION PERFORMED ON (B)(6) 2020. IMPLANT EXPLANTED, CLEAR SEROUS FLUID DRAINED, NO GROSS EVIDENCE OF INFECTION OBSERVED. INITIALLY REPORTED AS POSSIBLE INFECTION AND UNRELATED TO DEVICE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 11646251 ↗