safePICO70 956-615Recalls & reported problems
Radiometer Medical ApS · safePICO 23Gx16mm (nsd) Arterial blood sampler with 23Gx16mm needle, with needle shield device (nsd) and vented TIPCAP, 1.5 mL, box 100 pcs. · Class 2
All models of safePICO70 (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05700699566157), received between Jun 7, 2019 and Jan 14, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Fluid/Blood Leak1
- Insufficient Device Problem Information1
- Material Integrity Problem1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Exposure to Body Fluids1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 14, 2026Fluid/Blood Leak; Insufficient Device Problem Information
RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, ON (B)(6) 2026 WHILE USING THE SAFEPICO SAMPLER (LOT NUMBER: EE52), THE USER WAS CONTAMINATED WITH BLOOD FROM THE SAMPLER. THERE WAS A CRACK IN THE LOWER PART OF THE SAMPLER.
Patient problems: Exposure to Body Fluids
MAUDE report 24066111 ↗MalfunctionNov 9, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE COMPLAINT, A NURSE ENCOUNTERED DIFFICULTY HANDLING THE NEEDLE SHIELD DEVICE OF THE SAFEPICO (LOT NUMBER: NY-50).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18098864 ↗MalfunctionFeb 1, 2023Use of Device Problem; Use of Device Problem
ACCORDING TO THE COMPLAINT, THE NURSE FAILED TO ACTIVATE THE NSD (NEEDLE SHIELD DEVICE) ON A SAFEPICO. IT WAS LATER CONFIRMED THAT NO ONE WAS INJURED/PRICKED WITH THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16278819 ↗MalfunctionJun 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE COMPLAINT, THE CUSTOMER HAS EXPERIENCED ON SEVERAL OCCASIONS THAT THE NEEDLE SHIELD DEVICE OF THE SAFEPICO70 DOES NOT LOCK, ULTIMATELY RESULTING IN THE NEEDLE NOT BEING SAFE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8677956 ↗
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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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