CLASS II Device recall · Reported 6 Nov 2019 · FDA Enforcement Report
Synchro2 Standard Guidewire with Hydrophilic Coating recalled
Stryker Neurovascular is recalling Synchro2 Standard Guidewire with Hydrophilic Coating, UPN Product No. M00326410, distributed nationwide in the US. The recall was initiated on 8 Jun 2018 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-0229-2020
- FDA event ID
- 81108
- Recalling firm
- Stryker Neurovascular, Fremont, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jun 2018
- FDA classified
- 29 Oct 2019
- Reported
- 6 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 8 Jun 2018 | Recall initiated by company | |
| 29 Oct 2019 | Classified by FDA | +508 days |
| 6 Nov 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UPN: M00326410 Lot Numbers/UDI:0000000564/ (01)04546540688767(17)201031(10) 0000000564; 0000000565/ (01)04546540688767(17)201031(10)0000000565; 0000000566/(01)04546540688767(17)201031(10)0000000566; 0000000673/ (01)04546540688767(17)201031(10)0000000673; 0000000674/ (01)04546540688767(17)201031(10)0000000674; 0000000675/ (01)04546540688767(17)201031(10)0000000675; 0000000983/ (01)04546540688767(17)201031(10)0000000983; 0000000982/ (01)04546540688767(17)201031(10)0000000982; 0000001016/ (01)04546540688767(17)201031(10)0000001016; 0000001017/ (01)04546540688767(17)201031(10)0000001017; 0000001018/ (01)04546540688767(17)201031(10)0000001018; 0000001280/ (01)04546540688767(17)201031(10)0000001280; 0000001279/ (01)04546540688767(17)201031(10)0000001279; 0000001278/ (01)04546540688767(17)201031(10)0000001278; 0000001289/ (01)04546540688767(17)201031(10)0000001289; 0000001290/ (01)04546540688767(17)201031(10)0000001290; 0000001291/ (01)04546540688767(17)201031(10)0000001291; 0000001495/ (01)04546540688767(17)201031(10)0000001495; 0000001497/ (01)04546540688767(17)201031(10)0000001497; 0000001496/ (01)04546540688767(17)201031(10)0000001496; 0000001640/ (01)04546540688767(17)201130(10)0000001640; 0000001641/ (01)04546540688767(17)201130(10)0000001641; 0000001642/ (01)04546540688767(17)201130(10)0000001642; 0000000989/ (01)04546540688767(17)201031(10)0000000989; 0000001912/ (01)04546540688767(17)201130(10)0000001912; 0000001913/ (01)04546540688767(17)201130(10)0000001913; 0000001914/ (01)04546540688767(17)201130(10)0000001914; 0000001643/ (01)04546540688767(17)201130(10)0000001643; 0000002056/ (01)04546540688767(17)201130(10)0000002056; 0000002057/ (01)04546540688767(17)201130(10)0000002057; 0000002058/ (01)04546540688767(17)201130(10)0000002058; 0000002236/ (01)04546540688767(17)201130(10)0000002236; 0000002235/ (01)04546540688767(17)201130(10)0000002235; 0000002233/ (01)04546540688767(17)201130(10)0000002233; 0000002234/ (01)04546540688767(17)201130(10)0000002234; 0000002427/ (01)04546540688767(17)201231(10)0000002427; 0000002428/ (01)04546540688767(17)201231(10)0000002428; 0000002429/ (01)04546540688767(17)201231(10)0000002429; 0000002430/ (01)04546540688767(17)201231(10)0000002430; 0000002642/ (01)04546540688767(17)201231(10)0000002642; 0000002641/ (01)04546540688767(17)201231(10)0000002641; 0000002643/ (01)04546540688767(17)201231(10)0000002643; 0000002644/ (01)04546540688767(17)201231(10)0000002644; 0000002766/ (01)04546540688767(17)201231(10)0000002766; 0000002767/ (01)04546540688767(17)201231(10)0000002767; 0000002768/ (01)04546540688767(17)201231(10)0000002768; 0000002974/ (01)04546540688767(17)201231(10)0000002974; 0000002975/ (01)04546540688767(17)201231(10)0000002975; 0000002976/ (01)04546540688767(17)201231(10)0000002976; 0000003768/ (01)04546540688767(17)210131(10)0000003768; 0000003767/ (01)04546540688767(17)210131(10)0000003767; 0000003769/ (01)04546540688767(17)210131(10)0000003769; 0000003770/ (01)04546540688767(17)210131(10)0000003770; 0000003950/ (01)04546540688767(17)210131(10)0000003950; 0000004126/ (01)04546540688767(17)210131(10)0000004126; 0000004125/ (01)04546540688767(17)210131(10)0000004125; 0000004111/ (01)04546540688767(17)200124(10)0000004111; 0000004321/ (01)04546540688767(17)200130(10)0000004321; 0000004597/ (01)04546540688767(17)200205(10)0000004597; 0000004899/ (01)04546540688767(17)210228(10)0000004899; 0000004900/ (01)04546540688767(17)210228(10)0000004900; 0000004901/ (01)04546540688767(17)210228(10)0000004901; 0000005142/ (01)04546540688767(17)210228(10)0000005142; 0000005144/ (01)04546540688767(17)210228(10)0000005144; 0000005145/ (01)04546540688767(17)210228(10)0000005145; 0000005146/ (01)04546540688767(17)210228(10)0000005146; 0000005148/ (01)04546540688767(17)210228(10)0000005148; 0000005344/ (01)04546540688767(17)210228(10)0000005344; 0000005346/ (01)04546540688767(17)210228(10)0000005346; 0000005345/ (01)04546540688767(17)210228(10)0000005345; 0000005347/ (01)04546540688767(17)210228(10)0000005347; 0000005348/ (01)04546540688767(17)210228(10)0000005348; 0000005532/ (01)04546540688767(17)210331(10)0000005532; 0000005533/ (01)04546540688767(17)210331(10)0000005533; 0000005531/ (01)04546540688767(17)200301(10)0000005531; 0000005687/ (01)04546540688767(17)200305(10)0000005687; 0000005828/ (01)04546540688767(17)200307(10)0000005828; 0000004902/ (01)04546540688767(17)210228(10)0000004902; 0000004903/ (01)04546540688767(17)210228(10)0000004903; 0000005852/ (01)04546540688767(17)210331(10)0000005852; 0000005853/ (01)04546540688767(17)210331(10)0000005853; 0000005987/ (01)04546540688767(17)210331(10)0000005987; 0000005988/ (01)04546540688767(17)210331(10)0000005988; 0000005989/ (01)04546540688767(17)210331(10)0000005989; 0000006199/ (01)04546540688767(17)210331(10)0000006199; 0000006200/ (01)04546540688767(17)210331(10)0000006200; 0000006316/ (01)04546540688767(17)210331(10)0000006316; 0000006315/ (01)04546540688767(17)210331(10)0000006315; 0000006314/ (01)04546540688767(17)210331(10)0000006314; 0000006601/ (01)04546540688767(17)210325(10)0000006601; 0000006672/ (01)04546540688767(17)210326(10)0000006672; 0000006482/ (01)04546540688767(17)210331(10)0000006482; 0000006480/ (01)04546540688767(17)210331(10)0000006480; 0000006481/ (01)04546540688767(17)210331(10)0000006481; 0000006827/ (01)04546540688767(17)210401(10)0000006827; 0000006619/ (01)04546540688767(17)210331(10)0000006619; 0000006618/ (01)04546540688767(17)210331(10)0000006618; 0000006620/ (01)04546540688767(17)210331(10)0000006620; 0000007032/ (01)04546540688767(17)210407(10)0000007032; 0000007001/ (01)04546540688767(17)210430(10)0000007001; 0000006999/ (01)04546540688767(17)210430(10)0000006999; 0000007000/ (01)04546540688767(17)210430(10)0000007000; 0000007174/ (01)04546540688767(17)210410(10)0000007174; 0000007082/ (01)04546540688767(17)210408(10)0000007082; 0000007089/ (01)04546540688767(17)210430(10)0000007089; 0000007090/ (01)04546540688767(17)210430(10)0000007090; 0000007091/ (01)04546540688767(17)210430(10)0000007091; 0000007092/ (01)04546540688767(17)210410(10)0000007092; 0000007315/ (01)04546540688767(17)210430(10)0000007315; 0000007317/ (01)04546540688767(17)210430(10)0000007317; 0000007316/ (01)04546540688767(17)210430(10)0000007316; 0000007426/ (01)04546540688767(17)210430(10)0000007426; 0000007425/ (01)04546540688767(17)210430(10)0000007425; 0000007741/ (01)04546540688767(17)210422(10)0000007741; 0000007771/ (01)04546540688767(17)210423(10)0000007771; 0000007772/ (01)04546540688767(17)210423(10)0000007772; 0000009017.
Where was it sold?
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.
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
7 other products · FDA event 81108This product is part of a recall event; the main page for the event is Synchro2, SOFT Guidewire with Hydrophilic Coating recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Synchro2, SOFT Guidewire with Hydrophilic Coating recalled | Stryker Neurovascular | Other | Nationwide | |
| CLASS II | Synchro2, Soft Pre-shaped Guidewire recalled by Stryker Neurovascular | Stryker Neurovascular | Other | Nationwide | |
| CLASS II | Synchro2 Standard Pre-shaped Guidewire recalled by Stryker Neurovascular | Stryker Neurovascular | Other | Nationwide | |
| CLASS II | Synchro2 Standard Guidewire recalled by Stryker Neurovascular | Stryker Neurovascular | Other | Nationwide | |
| CLASS II | Synchro2 Standard Pre-shaped Guidewire recalled by Stryker Neurovascular | Stryker Neurovascular | Other | Nationwide | |
| CLASS II | Synchro2 SOFT Guidewire with Hydrophilic Coating recalled | Stryker Neurovascular | Other | Nationwide | |
| CLASS II | Synchro2, Soft Pre-shaped Guidewire recalled by Stryker Neurovascular | Stryker Neurovascular | Other | Nationwide |
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| Device | CLASS II | The Synchro Neuro Guidewires are a steerable guidewire recalled | Stryker Neurovascular | Other | Nationwide |
| Device | CLASS II | The Synchro Select Guidewires are a steerable guidewire recalled | Stryker Neurovascular | Other | Nationwide |
| Device | CLASS II | The Synchro2 Guidewires are a steerable guidewire family recalled | Stryker Neurovascular | Other | Nationwide |
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