K-Pack II KN-2525RBRecalls & reported problems
Terumo Europe NV · K-Pack II Needle · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 2
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05413206003815), received between Aug 22, 2025 and Apr 1, 2026 — classified as 2 deaths, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Break2
Patient problems
- Insufficient Information4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2026Break
TERUMO RECEIVED THE REPORTED INFORMATION. ON 05NOV2025, PICTURES OF THE FINISHED PRODUCT (FP) BATCH: LX4202 (F000042606), WERE VISUALLY CHECKED. IT WAS NOTICED THAT THE NEEDLE WAS BROKEN OFF THE NEEDLE HUB. THERE WAS NO PATIENT INJURY, AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE FINAL PATIENT IMPACT AND PROCEDURE OUTCOME WERE UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 16DEC2025: THE METAL NEEDLE DETACHED FROM THE CONE WHILE BEING WITHDRAWN FROM THE MUSCLE AFTER APPLICATION.
Patient problems: Insufficient Information
MAUDE report 24756255 ↗MalfunctionDec 29, 2025Break; Break
TERUMO RECEIVED THE REPORTED INFORMATION. ON 05NOV2025, PICTURES OF THE FINISHED PRODUCT (FP) BATCH LX4202 (F000042606), WERE VISUALLY CHECKED. IT WAS NOTICED THAT THE NEEDLE WAS BROKEN OFF THE NEEDLE HUB. THERE WAS NO PATIENT INJURY, AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE FINAL PATIENT IMPACT AND PROCEDURE OUTCOME WERE UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 16DEC2025: THE METAL NEEDLE DETACHED FROM THE CONE WHILE BEING WITHDRAWN FROM THE MUSCLE AFTER APPLICATION.
Patient problems: Insufficient Information
MAUDE report 23906532 ↗DeathAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEATH OF A CHILD OCCURRED. THE PROCEDURE OUTCOME WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 22873432 ↗DeathAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEATH OF A CHILD OCCURRED. THE PROCEDURE OUTCOME WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 22873431 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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