ClearanceBrief
Recall Z-0142-2025 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)

Physio-Control, Inc.

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. Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular t

DateOct 22, 2024 (initiated Aug 9, 2024)
StatusOpen, Classified
ReasonDue to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizable internal defibrillation paddles.
Root causeUnder Investigation by firm
ActionOn 09/27/2024, the firm send an "URGENT: MEDICAL DEVICE CORRECTION" Letter via US mail to customers informing them that Stryker has received several complaint reports indicating issues with Internal Paddles - 1) Paddles are not reaching the expected cleaning and sterilization cycle count designated in the Instructions for Use and are showing signs of cracking, and 2) Internal Paddles having a noticeable material separation between the white and gray silicone overmold material on the grip of the handle. Customer are instructed to: 1. Immediately check your internal inventory to locate the prod
Quantity3,617 devices (US-3315 and O.U.S - 302 devices)
DistributionWorldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Netherlands, and
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
Physio-Control, Inc., Jun 3, 2019