HAEMONETICS SMARTSUCTION TECHNOLOGY HAR-A-1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10812747017336), received between Oct 12, 2022 and Oct 12, 2022 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K052626); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2022Suction Failure

  MALFUNCTION OF THE CELL SAVER THAT OCCURRED DURING THIS CASE. IT'S AN OPEN ANEURYSM. THE CELL SAVER SUCTION WASN'T WORKING PROPERLY, THE VACUUM LINE AND ALSO THE ASPIRATION LINE WAS SWITCHED DURING THE CASE SO I DON'T KNOW IF THE PREVIOUS LINES THAT WERE HOOKED UP MALFUNCTIONED IN SOME WAY.

  Patient problems: Ruptured Aneurysm

  MAUDE report 15592614 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052626. One submission often covers many models, so check the product and lot details in each record.

• Z-0035-2007 · Jul 28, 2006 · Terminated
  SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US