safePICO70 956-612Recalls & reported problems
Radiometer Medical ApS · safePICO 23Gx16mm Arterial blood sampler with 23Gx16mm needle, with vented TIPCAP, 1.5 mL, box of 100 pcs. · Class 2
All models of safePICO70 (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05700699566126), received between Jul 14, 2025 and Jul 14, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).
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
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
RADIOMETER REFERENCE (B)(4). ACCORDING TO THE COMPLAINT, ON (B)(6) 2025, AT 8:38, A PATIENT VISITED THE HOSPITAL FOR TREATMENT. FOLLOWING THE DOCTOR'S ORDER FOR ARTERIAL BLOOD COLLECTION, THE NURSE DISCOVERED AFTER COLLECTING THE ARTERIAL BLOOD THAT THE SAFEPICO70 (LOT NO. CY50) LACKED THE BLUE PLASTIC CUBE USED FOR NEEDLE PROTECTION. THE NURSE IMMEDIATELY REPLACED IT WITH A SAFEPICO70 THAT INCLUDED A BLUE PLASTIC CUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22492845 ↗
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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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