AHTO 0250070601Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327052138), received between Jun 25, 2018 and Jan 13, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K042454); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2023Temperature Problem

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162204 ↗
• MalfunctionDec 3, 2019Thermal Decomposition of Device; Thermal Decomposition of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

  Patient problems: Burn, Thermal

  MAUDE report 9403724 ↗
• MalfunctionOct 3, 2018Thermal Decomposition of Device

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT. THERE WAS NO ASSOCIATED PROCEDURE AND NO REPORTS OF ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7931287 ↗
• MalfunctionJul 26, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT. THERE WAS NO ASSOCIATED PROCEDURE AND NO REPORTS OF ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7724115 ↗
• MalfunctionJun 25, 2018Melted

  IT WAS REPORTED THAT KETTLE LEAD STARTED TO MELT WHILE PLUGGED IN TO RECHARGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7636138 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042454. One submission often covers many models, so check the product and lot details in each record.

• Z-2862-2026 · Jun 8, 2026 · Open, Classified
  STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
• Z-2863-2026 · Jun 8, 2026 · Open, Classified
  STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
• Z-2864-2026 · Jun 8, 2026 · Open, Classified
  STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640
• Z-0836-2018 · Nov 17, 2017 · Terminated
  STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packagi
• Z-0279-06 · Nov 18, 2005 · Terminated
  StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520, 250-070-540, 250-070-600, 250-070-620; Product is distributed by Stryker Endos