The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip
Medical device recall Z-1939-2024. Published in FDA’s Enforcement Report on Jun 12, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 12, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 52 states named
- 105,286 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro 10 guidewire is 0.010in. The outside diameter of the Syncrho 14 guidewire is 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.
105,286, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Catalog/UDI-DI/Lots: M00316310/07613252187158/0000131357, 0000132153, 0000132740, 0000135026, 0000138147, 0000138148, 0000138579, 0000142533, 0000144961, 0000145874, 0000154419, 0000156324, 0000156614, 0000158907, 0000158911, 0000164603,…
Every code shown here, 1,992 characters
Catalog/UDI-DI/Lots: M00316310/07613252187158/0000131357, 0000132153, 0000132740, 0000135026, 0000138147, 0000138148, 0000138579, 0000142533, 0000144961, 0000145874, 0000154419, 0000156324, 0000156614, 0000158907, 0000158911, 0000164603, 0000173346, 0000173701, 0000173702, 0000173771, 0000173995; M00316330/07613252187165/0000142692, 0000158995; M00313010/07613252186922/0000129027, 0000129028, 0000129029, 0000129218, 0000129219, 0000129630, 0000129631, 0000129841, 0000129842, 0000129902, 0000130225, 0000130226, 0000130410, 0000130411, 0000130412, 0000130502, 0000130503, 0000130643, 0000130645, 0000130869, 0000130870, 0000131304, 0000131307, 0000131343, 0000131724, 0000131725, 0000131726, 0000132154, 0000132155, 0000132582, 0000132640, 0000132641, 0000133182, 0000133183, 0000133391, 0000133565, 0000133566, 0000133567, 0000133568, 0000133928, 0000133929, 0000134128, 0000134129, 0000134130, 0000134307, 0000134308, 0000135009, 0000135148, 0000135149, 0000135303, 0000135304, 0000135806, 0000135807, 0000136252, 0000136923, 0000137267, 0000137322, 0000137373, 0000137374, 0000137375, 0000138751, 0000139437, 0000141635, 0000142248, 0000142249, 0000142541, 0000142691, 0000143123, 0000143350, 0000143351, 0000143585, 0000143955, 0000144141, 0000144320, 0000144379, 0000144380, 0000144739, 0000144760, 0000144761, 0000144764, 0000144959, 0000144960, 0000145884, 0000145885, 0000146228, 0000146390, 0000146515, 0000146843, 0000146916, 0000147040, 0000147186, 0000147306, 0000147440, 0000147585, 0000147876, 0000148965, 0000149562, 0000150095, 0000150872, 0000150873, 0000151381, 0000151461, 0000151677, 0000151847, 0000151848, 0000152230, 0000152231, 0000152375, 0000152522, 0000152977, 0000153282, 0000153370, 0000153970, 0000154140, 0000154302, 0000154303, 0000154779, 0000154780, 0000154894, 0000154895, 0000155020, 0000155068, 0000156317, 0000156321, 0000156615, 0000156626, 0000156794, 0000156800, 0000157226, 0000157227, 0000157892, 0000157894, 0000158127, 0000158128, 0000158131,…
FDA’s list runs to 3,528 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
52 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Guam
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 18, 2024.
- FDA classified it on May 31, 2024.
- FDA’s Enforcement Report published it on Jun 12, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Neurovascular, of Fremont, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,528 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.