enFlow™ 980202EURecalls & reported problems
Airlife · Disposable IV Fluid/Blood Warmer Cartridge with IV Extension Model 202 · Class 2
- 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 10190752147102), received between Jul 12, 2026 and Jul 12, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Flush” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K130867); 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Flush1
- Infusion or Flow Problem1
Patient problems
- Loss of consciousness1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 12, 2026Difficult to Flush; Infusion or Flow Problem
IT WAS REPORTED THAT BLOOD PRODUCTS WERE GIVEN TO 6-MONTH-OLD VIA SYRINGE THEN INTO ENFLOW CASSETTE AND INTO PATIENT. IT WAS NOTICED WHILST GIVING THE BLOOD, AIR WAS ENTRAINED WHICH ENDED UP A NEAR FATAL EMBOLUS IN THE PATIENT. IT WAS NOTICED THAT THE ENFLOW CASSETTE WAS LEAKING FROM THE RIGHT SIDE OF THE CASSETTE NEAR THE PATIENT END WHICH WAS IN THE WARMING DEVICE.
Patient problems: Loss of consciousness
MAUDE report 25791700 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K130867. One submission often covers many models, so check the product and lot details in each record.
- Z-1386-2019 · Mar 13, 2019 · TerminatedenFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
- Z-1385-2019 · Mar 13, 2019 · TerminatedenFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
Other Warmer, thermal, infusion fluid devices
- Level 1 HL-90Icu Medical, Inc. · Warmer, thermal, infusion fluid991 reports
- Level 1 HL-390Icu Medical, Inc. · Warmer, thermal, infusion fluid634 reports
- Level 1 L-70Icu Medical, Inc. · Warmer, thermal, infusion fluid1 recall385 reports
- 3-Spike Disposable Set (1 Piece) 903-00006PBelmont Instrument Corporation · Warmer, Thermal, Infusion Fluid1 recall1 death97 reports
- Rapid Infuser RI-2, 120V, 750 ml/min 903-00039Belmont Instrument Corporation · Warmer, Thermal, Infusion Fluid132 reports
- Level 1 L-70NIIcu Medical, Inc. · Warmer, thermal, infusion fluid114 reports
- Rapid Infuser RI-2, 120V, 1000ml/min 903-00037Belmont Instrument Corporation · Warmer, Thermal, Infusion Fluid1 death76 reports
- Hyperthermia Pump Procedure Kit 902-00045Belmont Instrument Corporation · Warmer, Thermal, Infusion Fluid1 recall4 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.