ACL TOP 700 00000280010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08426950497974), received between Nov 28, 2017 and Nov 28, 2017 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K160276); 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.

• InjuryNov 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT THEIR ACL TOP 700 REPORTED 2 ERRONEOUSLY LOW APTT PATIENT RESULTS USING HEMOSIL SYNTHASIL. ONE PATIENT WAS GIVEN ADDITIONAL HEPARIN DUE TO THE LOWER RESULTS. HOWEVER, THERE WAS NO ADVERSE EFFECTS DUE TO THE EXTRA HEPARIN. THE RESULTS DID NOT MATCH PATIENT HISTORY AND WAS THEREFORE REPEATED. THE 2 SAMPLES WERE SUBSEQUENTLY CORRECTED.

  Patient problems: Therapeutic Response, Increased

  MAUDE report 7064403 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160276. One submission often covers many models, so check the product and lot details in each record.

• Z-1014-2022 · Feb 22, 2022 · Open, Classified
  ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065