Butterfly Network, Inc. Butterfly iQRecalls & reported problems
Butterfly Network, Inc. · Portable Ultrasound System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00866646000206), received between Dec 29, 2020 and Dec 29, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (1 report).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Feb 24, 2020Class IITerminated
Distributed without an approved 510(k)
Z-1600-2020 · Root cause: No Marketing Application · Recall details · FDA record ↗
Most reported problems
Device problems
- Contamination1
- Device Contamination with Chemical or Other Material1
- No Apparent Adverse Event1
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2020Contamination; Overheating of Device; Device Contamination with Chemical or Other Material; No Apparent Adverse Event; Device Contamination with Chemical or Other Material; No Apparent Adverse Event
ON (B)(6) 2020, A CUSTOMER REPORTED THAT THE BUTTERFLY IQ TRANSDUCER (PROBE) GOT HOT DURING THE LAST USE AND THAT THREE DAYS AFTER THE LAST USE, THE PROBE WAS FOUND TO HAVE A CRUSTY SUBSTANCE/MATERIAL ON THE OUTSIDE OF THE PROBE. FOLLOWING THE LAST USAGE, THE CUSTOMER REPORTED THAT THEY STORED THE PROBE IN A CLOTH POUCH AND DISCOVERED THE SUBSTANCE/MATERIAL THREE DAYS LATER, WHEN THE PROBE WAS REMOVED. FOLLOW UP INFORMATION PROVIDED BY THE CUSTOMER CONFIRMED THAT THE PROBE IS TYPICALLY STORED IN A CLOTH POUCH WITH PACKETS OF ULTRASOUND GEL. CUSTOMER PROVIDED PHOTOS CONFIRMED THE SUBSTANCE/MATERIAL. THE PROBE IS BEING RETURNED FOR INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11092102 ↗
Other Transducer, ultrasonic, diagnostic devices
- Site~Rite 8 Ultrasound System 9770603Bard Access Systems, Inc. · Transducer, ultrasonic, diagnostic620 reports
- ULTRASONIC PROBE UM-S20-17SOlympus Medical Systems Corp. · Transducer, ultrasonic, diagnostic2 deaths344 reports
- Transducer X7-2t 989605414122Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic6 recalls21 reports
- EPIQ Diagnostic Ultrasound System 989605488741Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic3 recalls165 reports
- bk3000, bk3500, bk5000, bkActiv 2300Bk Medical Aps · Transducer, Ultrasonic, Diagnostic6 recalls1 report
- Transducer L12-3 989605412072Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic5 recalls1 report
- Transducer L15-7io 989605387852Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic5 recalls0 reports
- Transducer eL18-4 EMT 989605431531Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic5 recalls0 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 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