ACL TOP 700 CTS 00000280050Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08426950497981), received between Dec 21, 2017 and Dec 21, 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 18, 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.

• InjuryDec 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS RECEIVED INDICATING THAT ACL TOP 700 CTS, S/N (B)(4), GENERATED XA RESULTS THAT CROSSED TO THEIR (B)(6) INFORMATION SYSTEM (LIS) AS <0.04 DUE TO A QC FLAG ASSOCIATED WITH THE RESULTS. FOUR PATIENTS WERE ADMINISTERED UNNECESSARY HEPARIN BASED ON REPORTED RESULTS. THERE WAS NO REPORTED ADVERSE EFFECT ON THE PATIENTS.

  Patient problems: Therapeutic Response, Increased

  MAUDE report 7138949 ↗

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 4. A