Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter

FDA device recall Z-0015-2024 · posted 2023-10-03 · Open, Classified

Recall details

Recalling firm

Boston Scientific Corporation

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 taken

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.

Root cause

Employee error

Status

Open, Classified

Product code

DQY

Quantity affected

1086 units

Distribution

US Nationwide distribution in the state of Indiana.

Date initiated

2023-07-27

Date posted

2023-10-03

Location

Maple Grove, MN