Infusion Pump Adverse Events and Recalls since 2024

FDA FRN infusion pumps — adverse events and recalls since January 2024

Scope: FDA product code FRN; MAUDE events from Jan 2024–May 2026 (June 2026 has no reported events in this import) and recalls initiated from Jan 2024 onward. See the reproducible FRN vigilance report.

Adverse-event trend

There were 133,591 MAUDE reports for FRN in the period: 131,626 malfunctions (98.5%), 1,689 injuries, 242 deaths, and 34 other reports. FRN vigilance report

Monthly pattern: reports peaked at 6,975 in February 2024, then generally ranged around 3,600–5,200 per month. The most recent complete-month volume was 4,822 in May 2026. FRN vigilance report

Most frequently coded device problems:

1. Device sensing problem — 17,761
2. Break — 16,623
3. Corroded — 15,415
4. Device alarm system — 11,923
5. Failure to sense — 8,600
6. Failure to infuse — 5,835
7. Improper flow or infusion — 4,022
8. Excess flow or over-infusion — 3,167
   FRN vigilance report

Recalls

The database identifies 84 FRN recalls initiated in the reporting period; the report’s recall listing is truncated to recent entries. Related enforcement records include 40 Class I, 47 Class II, and 1 Class III entries. FRN vigilance report

Recent examples:

Interpretation caveat

MAUDE report counts are not incidence rates and can include follow-up, retrospective, or manufacturer-submitted reports. FDA data in this database are periodically imported; for time-critical recall status or newly issued communications, confirm against the official FDA record. Data coverage here runs through May 2026. FRN vigilance report