QUIKCLOT IPN928786Recalls & reported problems
Teleflex Incorporated · QuikClot Interventional Pre-Slit w/ Tegaderm · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841495150248), received between Apr 9, 2025 and Apr 10, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Lack of Effect” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Lack of Effect3
Patient problems
- Hemorrhage/Blood Loss/Bleeding3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2025Lack of Effect; Lack of Effect
IT WAS REPORTED THAT: "STAFF IN MICU WERE TRIALING/EVALUATING PRE-SLIT FOR CVC LINE BLEEDING/OOZING. AFTER INITIAL PLACEMENT OF GAUZE WAS SATURATED AND REPLACED AGAIN AND SAME OCCURRENCE AND REPLACED AGAIN. HEMOSTASIS WAS NOT ACHIEVED SO ALTERNATIVE ACTIONS TAKEN 3 FAILED ATTEMPTS. ACCORDING TO THE (B)(6) THERE WAS NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT." ASSOCIATED COMPLAINTS 3011137372-2025-00117 AND 3011137372-2025-00115.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21812662 ↗MalfunctionApr 9, 2025Lack of Effect; Lack of Effect
IT WAS REPORTED THAT: "STAFF IN MICU WERE TRAILING/EVALUATING PRE-SLIT FOR CVC LINE BLEEDING/OOZING. AFTER INITIAL PLACEMENT OF GAUZE WAS SATURATED AND REPLACED AGAIN AND SAME OCCURRENCE AND REPLACED AGAIN. HEMOSTASIS WAS NOT ACHIEVED SO ALTERNATIVE ACTIONS TAKEN 3 FAILED ATTEMPTS. ACCORDING TO THE NM THERE WAS NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT." ASSOCIATED COMPLAINTS 3011137372-2025-00117, 3011137372-2025-00115 AND 3011137372-2025-00116.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21806168 ↗MalfunctionApr 9, 2025Lack of Effect; Lack of Effect
IT WAS REPORTED THAT: "STAFF IN MICU WERE TRIALING/EVALUATING PRE-SLIT FOR CVC LINE BLEEDING/OOZING. AFTER INITIAL PLACEMENT OF GAUZE WAS SATURATED AND REPLACED AGAIN AND SAME OCCURRENCE AND REPLACED AGAIN. HEMOSTASIS WAS NOT ACHIEVED SO ALTERNATIVE ACTIONS TAKEN 3 FAILED ATTEMPTS. ACCORDING TO THE NM THERE WAS NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT." ASSOCIATED COMPLAINTS (B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21806162 ↗
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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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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