PICO70 956-522Recalls & reported problems
Radiometer Medical ApS · PICO70 22gx25mm Arterial blood sampler w. 22gx25mm needle, 1.5 mL, box of 100 pcs · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05700699565228), received between Dec 21, 2016 and Dec 4, 2019 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Corroded” (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.
Most reported problems
Device problems
- Corroded2
- Insufficient Device Problem Information1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE COMPLAINT, AT (B)(6) A USER COLLECTED BLOOD WITH A PICO70 FOR A BLOOD GAS ANALYSIS. IN THE PROCESS OF COLLECTING ARTERIAL BLOOD, THE NEEDLE HURT THE USER'S FINGER WHEN THE TIP OF THE NEEDLE WAS INSERTED INTO THE RUBBER. WHEN THE USER'S FINGER WAS STABBED, THE WOUND WAS IMMEDIATELY DISINFECTED AND BANDAGED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9408424 ↗MalfunctionJul 16, 2019Corroded; Corroded
ACCORDING TO THE COMPLAINT, IT LOOKS LIKE CORROSION ATTACHED ON THE SURFACE OF THE NEEDLES PICO70 (956-522).
Patient problems: No Patient Involvement
MAUDE report 8792594 ↗MalfunctionDec 21, 2016Corroded; Corroded
ACCORDING TO THE COMPLAINT, THE NEEDLE IS RUSTY. THE COMPLAINT CONCERNS THE FOLLOWING AMOUNT OF PRODUCTS: 956-522 LOT UB52 7 SAMPLERS, 956-522 LOT RV53 2 SAMPLERS, 956-522 LOT RW-55 6 SAMPLERS. THE SAMPLERS WAS NOT TAKEN INTO CLINICAL USE, AS THE USER DETECTED THE NEEDLE COATING DURING A CHECK OF THE STORAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6192513 ↗
Other Tubes, vials, systems, serum separators, blood collection devices
- BD Vacutainer® SST™ 367986Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection2 recalls2,711 reports
- BD Vacutainer® Buffered Sodium Citrate (9NC) Blood Collection Tubes 363083Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall1,744 reports
- BD Vacutainer® SST™ II Advance 367955Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection1,478 reports
- BD Vacutainer® Eclipse™ Blood Collection Needle 368607Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1,220 reports
- BD Vacutainer® SST™ 367983Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection2 recalls1,075 reports
- BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367856Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1,010 reports
- BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units 367960Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall747 reports
- BD Vacutainer® SST™ II Advance 367957Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection767 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page