Internal Defibrillation Paddles Recalled for Cracks and Separation
Physio-Control is recalling sterilizable internal defibrillation paddles (LP20 and LP15 models) due to cracking and over-molding separation. The defects may prevent proper device function during critical cardiac emergency treatment.
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: This is an FDA Class II voluntary recall with no reported illnesses or injuries. However, the structural defects in critical life-saving defibrillation paddles pose a significant risk of harm by potentially preventing proper delivery of cardiac therapy during medical emergencies.
Plain-English summary
Physio-Control, Inc. is conducting a voluntary recall of sterilizable internal defibrillation paddles (LP20 and LP15 models). The recall affects approximately 3,617 devices distributed throughout the United States and internationally including Australia, Canada, the Netherlands, and New Zealand.
The recall was initiated due to structural defects identified through customer complaints and out-of-box failures. Affected paddles exhibit cracking and over-molding separation, which may compromise proper electrical contact and device function.
These paddles are used to treat potentially life-threatening cardiac arrhythmias including ventricular fibrillation and ventricular tachycardia. They are also used for synchronized cardioversion. Structural failure of the paddles could prevent proper delivery of therapy during critical medical situations.
The recalled product
- Product
- STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.…
- Manufacturer
- Physio-Control, Inc.
Distribution
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