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U.S. Department of Health and Human Services

Class 2 Device Recall Guider Softip XF Guide Catheter

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  Class 2 Device Recall Guider Softip XF Guide Catheter see related information
Date Initiated by Firm July 27, 2023
Date Posted October 03, 2023
Recall Status1 Open3, Classified
Recall Number Z-0016-2024
Recall Event ID 92785
Product Classification Catheter, percutaneous - Product Code DQY
Product Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter
Code Information GTIN 08714729283515, Lot/Batch Numbers: 25651754, 25651753, 25761245, 26059691, 26409982, 26599707, 27219434 ****recall letter has more lot numbers****
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact Rebecca KinKead Rubio
763-494-1133
Manufacturer Reason
for Recall		 Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
FDA Determined
Cause 2		 Employee error
Action Stryker issued an URGENT: MEDICAL DEVICE VOLUNTARY Recall notice to it consignees on 07/31/2023. The notice explained the issue, potential risk, and required the following actions be taken: 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.
Quantity in Commerce 326 units
Distribution US Nationwide distribution in the state of Indiana.
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.
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