CLASS II ONGOING Device recall · Reported 12 Jun 2024 · FDA Enforcement Report
The Synchro Neuro Guidewires are a steerable guidewire recalled
Stryker Neurovascular is recalling The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip, distributed nationwide in the US. The recall was initiated on 18 Apr 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1939-2024
- FDA event ID
- 94543
- Recalling firm
- Stryker Neurovascular, Fremont, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Apr 2024
- FDA classified
- 31 May 2024
- Reported
- 12 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 18 Apr 2024 | Recall initiated by company | |
| 31 May 2024 | Classified by FDA | +43 days |
| 12 Jun 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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, 0000158339, 0000158340, 0000159324, 0000159932, 0000159997, 0000159998, 0000160368, 0000160369, 0000160434, 0000160435, 0000160893, 0000160894, 0000160895, 0000161061, 0000161062, 0000161063, 0000162104, 0000162105, 0000162106, 0000162896, 0000162991, 0000162992, 0000163716, 0000163967, 0000163968, 0000164443, 0000164470, 0000165356, 0000165363, 0000165364, 0000166540, 0000166542, 0000166544, 0000170149, 0000170246, 0000170940, 0000171065, 0000171235, 0000172266, 0000172267, 0000172381, 0000172787, 0000172865, 0000172866, 0000173279, 0000174292, 0000174373, 0000174380, 0000174409, 0000174680, 0000174681, 0000175067, 0000175068, 0000175069, 0000175640, 0000175641, 0000175983, 0000175984, 0000175985, 0000175986, 0000176344, 0000176345, 0000176504, 0000176523, 0000176830, 0000176836, 0000177535, 0000178075, 0000178076, 0000178532, 0000178533, 0000178535, 0000178626, 0000179628, 0000179629, 0000180361, 0000180738, 0000180800, 0000193546; M00313020/07613252186939/0000159372, 0000172593; M00313310/07613252186946/0000135007, 0000135008, 0000136409, 0000136410,0000136679, 0000139937, 0000139938, 0000140307, 0000140689, 0000140690, 0000141634, 0000141833, 0000142246, 0000152799, 0000153160, 0000153453, 0000153968, 0000153969, 0000154301, 0000157222, 0000157223, 0000157224, 0000159320, 0000159370, 0000160740, 0000172380, 0000172594, 0000172619, 0000172661, 0000172662, 0000172748, 0000172786, 0000176476, 0000176840, 0000176841, 0000177540, 0000178232, 0000180657, 0000180737, 0000180795; M00313410/07613252186960/0000173997
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 94543This product is part of a recall event; the main page for the event is The Synchro2 Guidewires are a steerable guidewire family recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | The Synchro2 Guidewires are a steerable guidewire family recalled | Stryker Neurovascular | Other | Nationwide | |
| CLASS II | The Synchro Select Guidewires are a steerable guidewire recalled | Stryker Neurovascular | Other | Nationwide |
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