safePICO70 956-614Recalls & reported problems
Radiometer Medical ApS · safePICO 22Gx32mm (nsd) Arterial blood sampler with 22Gx32mm needle, with needle shield device (nsd) and 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05700699566140), received between May 7, 2022 and Aug 5, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Fail-Safe 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.
Most reported problems
Device problems
- Fail-Safe Problem1
- Use of Device Problem1
Patient problems
- Insufficient Information1
- Needle Stick/Puncture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 5, 2022Use of Device Problem; Use of Device Problem
ACCORDING TO THE COMPLAINT, ON AN UNKNOWN DATE, A USED NEEDLE WAS THROWN INTO THE GARBAGE BAG WITHOUT USING THE SAFEGUARD. WHEN A NURSE THEN TRIED TO THROW THE GARBAGE BAG AWAY, SHE WAS PRICKED BY THE USED NEEDLE. ACCORDING TO THE HOSPITAL'S RULES, SAFEGUARDS SHALL BE USED AND THROWN INTO THE SPECIAL PLASTIC TRASH CAN. THIS CASE IS THEREFORE CONSIDERED A USER ERROR.
Patient problems: Needle Stick/Puncture
MAUDE report 15173663 ↗InjuryMay 7, 2022Fail-Safe Problem; Fail-Safe Problem
ACCORDING TO THE COMPLAINT A CUSTOMER STAFF STUNG HIM/HERSELF WITH SAFEPICO NEEDLE. ACCORDING TO THE SALES REPRESENTATIVE, IT SEEMS THAT THE CUSTOMER HAS NOT LOCKED THE SAFEGUARD COMPLETELY. THE CASE IS CLEARLY A USER ERROR.
Patient problems: Insufficient Information
MAUDE report 14314509 ↗
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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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