Deltec 21-2938-24Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Deltec (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10610586023217), received between Jul 25, 2018 and Jul 25, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).
1 other recall cover devices cleared under the same FDA submission (K870866); they may or may not involve this specific model.
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
- Deformation Due to Compressive Stress1
Patient problems
- Extravasation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 25, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
USER FACILITY REPORTED THAT AN ONCOLOGY PATIENT WITH AN IMPLANTABLE VENOUS ACCESS SYSTEM EXPERIENCED INFILTRATION OF CYTOTOXIC CHEMOTHERAPY DRUG NEAR THE CLAVICULAR AREA (6 CM FROM ACCESS SITE) APPROXIMATELY 15 MINUTES AFTER BEGINNING INFUSION THERAPY. THE EXTRAVASATION SITE WAS IMAGED VIA CONTRAST XRAY AND EVIDENCE OF KINKING OF THE EXTERNAL CONNECTION AT 5 CM AT THE CLAVICULAR LEVEL WAS FOUND. MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE CATHETER FROM THE PATIENT. NO OTHER PATIENT OR DEVICE DETAILS WERE PROVIDED.
Patient problems: Extravasation
MAUDE report 7720089 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K870866. One submission often covers many models, so check the product and lot details in each record.
- Z-0189-2020 · Jul 8, 2019 · TerminatedGRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX; 3. NDL
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 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.
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