Stryker Neurovascular: Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326520, REF 2652, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

Recall number

Z-0232-2020

Recalling firm

Stryker Neurovascular

Product

Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326520, REF 2652, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

Status

Terminated

Initiated

2018-06-08

Posted

2019-10-29

Terminated

2021-04-28

Reason

The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

Root cause

Employee error

Action

On 6/08/18, "Urgent Medical Device Voluntary Customer Communication" were mailed via courier. The firm informed its customers that it has become aware that the product label (pouch and carton) for the affected products contain an incorrect value in millimeters (0.036 mm) for the Guidewire Outer Diameter dimension, but there will be no products being recalled. The Customer Notification Letter instructs customers to read this communication carefully and complete the following actions: 1. Immediately check your inventory. 2. Review the Communication and ensure full understanding of the contents. 3. Circulate this Customer Communication internally to all interested/affected parites. 4. Inform the Recalling Firm if any of the subject devices have been distributed to other organizations. 5. Please provide contact details so that the Recalling Firm can inform the recipients appropriately. 6. Please inform the Recalling Firm of any adverse events concening the use of the subject devices. 7. Return the completed form to your nominated Sales Representative of to NVFieldActions@stryker.com. 8. The Recalling Firm is requesting that customers respond to the Customer Communication within 7 calendar days for the date of receipt and a target date for completion of this action is 30 June 2018.

Quantity

305

Distribution

Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.

Lot, serial or model codes

UPN: M00326520  Lot Numbers/UDI: 0000002431/ (01)04546540688798(17)201231(10)0000002431; 0000002645/ (01)04546540688798(17)201231(10)0000002645; 0000002771/ (01)04546540688798(17)201231(10)0000002771; 0000006204/ (01)04546540688798(17)210331(10)0000006204; 0000006875/ (01)04546540688798(17)210401(10)0000006875; 0000007429/ (01)04546540688798(17)210430(10)0000007429;

510(k) numbers

["K190843"]

PMA numbers

not on file

Product code

DQX

Firm FEI

3008853977

Firm city

Fremont

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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