Class 2 Device Recall Boston Scientific Guider Softip XF

• Date Initiated by Firm: August 09, 2022
• Date Posted: August 25, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1582-2022
• Recall Event ID: 90735
• 510(K)Number: K010853 K980453
• Product Classification: Catheter, percutaneous - Product Code DQY
• Product: Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
• Code Information: UDI/DI 08714729202486, Lot/Batch 27339850, Use By 2021-05-18, and UPDATE: Lot/Batch 29308869, Use By 4/27/2025.
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 1 Scimed Pl; Maple Grove MN 55311-1565
• For Additional Information Contact: Rebecca KinKead Rubio; 763-494-1113
• Manufacturer Reason for Recall: The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
• FDA Determined Cause: Process control
• Action: Stryker notified its consignees by issuing an URGENT: MEDICAL DEVICE VOLUNTARY Recall notice on 8/9/2022 by courier. The notice described the problem and the hazard, and requested the consignee take the following actions: "Required Actions 1. Immediately check your internal inventory for affected devices. 2. Segregate the affected units in a secure location for return to Stryker. 3. Circulate this Recall-Removal notice internally to all interested/affected parties. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. Inform Stryker if any of the subject devices have been distributed to other organizations. If yes, provide contact details so that Stryker can inform the recipients appropriately. 6. Please inform Stryker of any adverse events concerning the use of the subject devices. 7. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. 8. Return the completed form to your local Stryker Contact. 9. Product Return Information will be provided to you by your designated Sales Representative." UPDATE: On/about 2/13/2023, the amended letter was issued. It identified the lot number (which was in addition to the lot number in the initial recall) and provided the same instructions as were contained in the original notice issued 8/9/2022.
• Quantity in Commerce: 184 devices (UPDATED)
• Distribution: International distribution in the countries of Greece, France, Germany, Italy, Brazil and South Korea. UPDATE: The devices were also distributed to Russia. There was no U.S. distribution.
• 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 = DQY and Original Applicant = BOSTON SCIENTIFIC SCIMED, INC.; 510(K)s with Product Code = DQY and Original Applicant = BOSTON SCIENTIFIC, TARGET