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Open, Classified

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 tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.

FDA Recall Z-0142-2025 · Posted 2024-10-22

Recalling FirmPhysio-Control, Inc.
Recall StatusOpen, Classified
Product CodeLDD
Date Initiated2024-08-09
Product Quantity3,617 devices (US-3315 and O.U.S - 302 devices)

Reason for Recall

Due 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.

Firm Action

On 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 product listed on the attached business reply form. 2. To confirm receipt of this Medical Device Notice and understanding of the provided information, please email the enclosed Business Reply Form (BRF) by October 15th, 2024 to [email protected] 3. It is important to follow the steps as outlined in the Pre-Surgical Check section of the Instructions for Use (IFU). If any damage or malfunction is found, remove the internal paddles from use immediately and contact your local Stryker representative for assistance. 4. Please continue to follow the Instructions for Use for the Sterilizable Internal Defibrillation Paddles for additional troubleshooting steps. For questions/assistance - contact Stryker Customer Service at +1 800 787 9537, option 2, from 8:00 AM to 7:00 PM (Eastern Time), Monday Friday or by email at [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide - 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 New Zealand.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc. · 2019-06-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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