Ptensys Bleeding Control Station TM-400Recalls & reported problems
TyTek Medical Inc. · Ptensys Bleeding Control Station · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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.
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.
Recalls naming this device
- Oct 5, 2020Terminated
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
Z-2611-2023 · Root cause: Device Design · Recall details · FDA record ↗
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- CVS Health 998842Woonsocket Prescription Center, Incorporated · First Aid Kit Without Drug1 recall0 reports
- Lucky Super Soft KitDelta Brands Inc. · First Aid Kit Without Drug1 recall0 reports
- CURAD CUR1625V1Medline Industries, Inc. · First aid kit without drug4 reports
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 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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