Defibtech DDU-100 Lifeline AED Recalled for Untested Component Risk
Defibtech is recalling 29 units of the DDU-100 Lifeline AED due to an untested component that could cause device failure. The affected device may not deliver therapy if a malfunction occurs.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a medical device with untested components that could fail to deliver critical therapy during a cardiac emergency. No injuries or illnesses reported, classifying this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Defibtech, LLC is recalling 29 units of the DDU-100 Lifeline Automated External Defibrillator (AED) used to treat sudden cardiac arrest. The recalled units were distributed nationwide.
A component within a sub-assembly of the affected AEDs had not undergone required durability and reliability testing. This untested component creates a risk of device malfunction during use.
If a malfunction occurs, the affected device could fail to deliver therapy to a patient experiencing sudden cardiac arrest. AEDs are critical emergency devices, and failure to deliver therapy could have serious consequences.
If you own or have access to one of the affected units, verify the serial number against the FDA's recall list. Contact Defibtech, LLC for instructions on obtaining a replacement or repair.
The recalled product
- Product
- DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
- Manufacturer
- Defibtech, LLC
- Category
- Medical Device — Defibrillator
- Affected units
- 29
Distribution
Distributed nationwide across the United States.
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