Class 2 Device Recall STERILIZABLE INTERNAL DEFIBRILLATION PADDLES

• Date Initiated by Firm: August 09, 2024
• Date Posted: October 22, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0142-2025
• Recall Event ID: 95242
• 510(K)Number: K182503
• Product Classification: Dc-defibrillator, low-energy, (including paddles) - Product Code LDD
• 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. Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.
• Code Information: LP20 Model/Catalog Number: 11131-000040 UDI-DI codes: 00883873863558 Part Number: 3317813-001 Serial Numbers: 101648901 86557878 87141562 88458193 88482392 93989670 Part Number: 3317813-005 Serial Number: 107741863 Model/Catalog Number: 11131-000041 UDI-DI code: 00883873863534 Part Number: 3317813-002 Serial Numbers: 86287034 86949592 90445090 91624045 93441890 Part Number: 3317813-006 Serial Number: 107556559 Model/Catalog Number: 11131-000042 UDI-DI code: 00883873863527 Part Number: 3317813-003 Serial Numbers: 100198569 100759224 101002312 101042672 101383090 84830138 84881382 84915416 86240215 86260453 86557878 86949593 87794908 90445091 91380577 92185462 96496375 96496376 96496377 97059498 Part Number: 3317813-007 Serial Numbers: 105817428 106332158 107556560 Model/Catalog Number: 11131-000043 UDI-DI code: 00883873863510 Part Number: 3317813-004 Serial Numbers: 101506304 86949594 90445092 LP15 Model/Catalog Number: 11131-000044 UDI-DI code: 00883873863503 Part Number: 3317814-001 Serial Numbers: 90445093 93441892 98719352 98719353 99649024 99649025 Part Number: 3317814-005 Serial Number: 107124577 Model/Catalog Number: 11131-000045 UDI-DI code: 00883873863497 Part Number: 3317814-003 Serial Numbers: 101888461 101888462 101888463 102107169 103669336 103669337 104125087 104129892 104440600 86280420 90445095 92556517 92871913 95836040 97111384 98719364 98719365 98813631 99692098 Part Number: 3317814-007 Serial Numbers: 106555464 106721716 106917875 106968460 107445069 107741891 Model/Catalog Number: 11131-000046 UDI-DI code: 00883873863480 Part Number: 3317814-004 Serial Numbers: 90445096 98719376 98813643 98990261 99692108 Part Number: 3317814-008 Serial Numbers: 107124605 Model/Catalog Number: 11131-000047 UDI-DI code: 00883873863213 Part Number: 3317814-002 Serial Numbers: 84830141 90445094 91515844 92556516 92871911 93441893 98719358 98719359 99692092 Part Number: 3317814-006 Serial Numbers: 107078533 107445059
• Recalling Firm/ Manufacturer: Physio-Control, Inc.; 11811 Willows Rd Ne; Redmond WA 98052-2003
• For Additional Information Contact: Joyce Staggs; 425-867-4597
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by 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 RSRecall@Stryker.com 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 medtechsup@stryker.com.
• Quantity in Commerce: 3,617 devices (US-3315 and O.U.S - 302 devices)
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LDD