FDA Device Recall Z-0012-2024: Boston Scientific Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0012-2024.

Recall Res Number

Z-0012-2024

Recalling Firm / Manufacturer

Boston Scientific Corporation

FEI Number

3002095335

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2023-07-27

Date Posted

2023-10-03

Date Terminated

N/A

Product Code

DQY

Event Number

92785

Product Quantity

2245 units

Product Description Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter

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.

Action Details 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.

Distribution Pattern US Nationwide distribution in the state of Indiana.

Code Information / Serial Numbers GTIN 08714729202509, Lot/Batch Numbers: 26059397, 26338716, 25822912, 25822914, 25822915, 25822916, 26059642, 26584704, 26585219, 26745658, 26745659, 26891768, 27177893, 27412261, 27504202, 27568860, 27754498, 27816607, 28100259, 28384661, 28502671, 28737894, 28737895, 26745657, 27177892, 28320873, 28584618, 28795038

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Medical Device Recall: Z-0012-2024

Recall Parameters & Description

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