HR-ACT 402-03Recalls & reported problems
Medtronic, Inc. · CARTRIDGE 402-03 ACT HR 13 LAN · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Oct 20, 2025Open, Classified
Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.
Z-0539-2026 · Root cause: Under Investigation by firm · FDA record ↗
Other ACTIVATED WHOLE BLOOD CLOTTING TIME devices
- Hemochron Whole Blood Microcoagulation System JACT-LRAccriva Diagnostics Holdings, Inc. · Activated Whole Blood Clotting Time1 recall1 death2 reports
- i-STAT 03P87-25Abbott Point Of Care Inc. · ACTIVATED WHOLE BLOOD CLOTTING TIME46 reports
- i-STAT 03P86-25Abbott Point Of Care Inc. · ACTIVATED WHOLE BLOOD CLOTTING TIME27 reports
- Hemochron Whole Blood Microcoagulation System JACT+Accriva Diagnostics Holdings, Inc. · Activated Whole Blood Clotting Time1 death1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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