Z-1940-2024Class II

The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in...

Name: Z-1940-2024 The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in...
Creator: Stryker Neurovascular
Published: 2024-04-18
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2024-04-18 / Open, Classified / root cause: design

FDA source

Stryker Neurovascular began a recall of The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside... on 2024-04-18. FDA classified it as Class II and gives the reason as "Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1940-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-18
Posted: 2024-05-31
Recalling firm: Stryker Corp.
Product: The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014in. The guidewires are compatible with existing microcatheters used in common procedures such as those used in endovascular diagnosis and therapy of neurovascular disease. The distal portion of the guidewire tip is radiopaque. For lubricity, the distal portion of the device is coated with a hydrophilic polymer and the proximal portion of the guidewire is coated with polytetrafluoroethylene (PTFE). The torque device included with the guidewire attaches to the proximal end of the wire and functions as a steering guide. Rotation of this device facilitates guidewire placement into the appropriate vessel by precise directional manipulation of the guidewire tip. The introducer included with the guidewire is intended to aid insertion of the guidewire into the catheter hub and/or hemostasis valve.
Product code: MOF Guide, Wire, Catheter, Neurovasculature
Reason for recall: Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 4/29/24, recall notices were mailed to Supply Chain Management/ Recall Coordinator/ Inventory Manager customers who were asked to do the following: 1) When using impacted guidewires, please do not backload the guidewire, follow the Instructions for Use (IFU) provided with the device, and do not use the guidewire if you see any visible signs of coating damage. 2) Circulate this customer notification internally to all interested/affected parties. 3) Inform firm if any of the subject devices have been distributed to other organizations. If yes, provide contact details so that the firm can inform the recipients appropriately. 4) Inform firm of any adverse events concerning the use of the subject devices. (US Customer Service: 1-855-91-NEURO (1-855-916-3876), Email: [email protected]) 5) Complete and return the customer response form via email to: [email protected]. 6) Contact the firm if you would like a replacement of the guidewire with a new optional introducer accessory.
Quantity in commerce: 41,074
Distribution: Worldwide - US Nationwide distribution including in the states of TX, NY, MD, CA, KY, WI, OR, NE, SC, MA, MO, CT, ID, PA, TN, FL, NC, AL, IA, OK, VA, IL, OH, NH, MN, ND, KS, NJ, WV, IN, GA, HI, AR, UT, LA, MI, WA, NV, CO, AZ, DC, VT, ME, DE, AK, WY, MT, NM, SD, MS, RI, GU and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, IRAN, IRELAND, ISRAEL, ITALIA, JAPAN, JORDAN, KUWAIT, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NORTHERN IRELAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UAE, UK.
Product codes and lots: Catalog/UDI-DI/Lots: SSFT215PRE/07613327508598/0000139994, 0000144321, 0000146842, 0000154408; SSFT215STR/07613327508574/0000122897, 0000123151, 0000123405, 0000124931, 0000125040, 0000125719, 0000125720, 0000125787, 0000126356, 0000129220, 0000129221, 0000130861, 0000131723, 0000132954, 0000133179, 0000137045, 0000138580, 0000138581, 0000142280, 0000142281, 0000143349, 0000143584; SSFT300STR/07613327508581/0000144375, 0000155022; SSTD215PRE/07613327508512/0000122145, 0000122866, 0000127369, 0000139986, 0000140672, 0000141825, 0000141826, 0000143802, 0000146926, 0000149561, 0000154409, 0000154410, 0000154411, 0000176472; SSTD215STR/07613327508499/0000122481, 0000122485, 0000122650, 0000123069, 0000123070, 0000123143, 0000125409, 0000127494, 0000127495, 0000128254, 0000128446, 0000128447, 0000131661, 0000131667, 0000131668, 0000133396, 0000133563, 0000133564, 0000140971, 0000141392, 0000141393, 0000142532, 0000143125, 0000143209, 0000143806, 0000143834, 0000144140, 0000148427, 0000148428, 0000148477, 0000149560, 0000154679, 0000154680, 0000154681, 0000155021, 0000155662, 0000156792, 0000164588, 0000164589, 0000164591, 0000172898, 0000172899, 0000172900, 0000172911, 0000175987, 0000176018, 0000176019; SSTD300STR/07613327508505/0000145095, 0000145694, 0000151281; SSUP215PRE/07613327508635/0000144317, 0000148425; SSUP300PRE/07613327508642/0000145692, 0000151280; SSUP215STR/07613327508611/0000128253, 0000129625, 0000137050, 0000140671, 0000141784, 0000143342, 0000144318, 0000145693, 0000145875, 0000164662, 0000165477; SSUP300STR/07613327508628/0000121919, 0000141789, 0000145691

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1940-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1939-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-05-31
Z-1940-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-05-31
Z-1941-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-05-31

Product code MOF

K202522Class IISynchro SELECT GuidewireStryker Neurovascular / cleared 2020-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)