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SYNCHRO 2

Model M00326010 · Stryker Corporation · DI 04546540688729

DQX — Wire, Guide, Catheter · Class II · 21 CFR 870.1330

UDILibrary device dossier · generated 2026-09-16 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (14)

InitiatedRecall #ClassStatusReasonLink basis
2024-04-18Z-1941-2024Class IIOpen, ClassifiedStryker 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.code info di
2018-06-08Z-0225-2020Class IITerminatedThe 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.code info di
2010-06-07Z-0875-2011TerminatedThe Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system.k number procode
2010-06-07Z-0871-2011TerminatedThe Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system.k number procode
2010-06-07Z-0872-2011TerminatedThe Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system.k number procode
2010-06-07Z-0873-2011TerminatedThe Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system.k number procode
2010-06-07Z-0874-2011TerminatedThe Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system.k number procode
2010-06-07Z-0868-2011TerminatedThe Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system.k number procode
2010-06-07Z-0869-2011TerminatedThe Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system.k number procode
2010-06-07Z-0870-2011TerminatedThe Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system.k number procode
2010-06-03Z-2069-2010TerminatedBoston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic polymer and the proximal portion is coated with polytetrafluoroethylene (PTFE). Through internal inspection process, the firm determined that Fathom guidewires from affected lots may exhibit a Pk number procode
2010-06-03Z-2070-2010TerminatedBoston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic polymer and the proximal portion is coated with polytetrafluoroethylene (PTFE). Through internal inspection process, the firm determined that Fathom guidewires from affected lots may exhibit a Pk number procode
2010-06-03Z-2071-2010TerminatedBoston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic polymer and the proximal portion is coated with polytetrafluoroethylene (PTFE). Through internal inspection process, the firm determined that Fathom guidewires from affected lots may exhibit a Pk number procode
2010-06-03Z-2068-2010TerminatedBoston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic polymer and the proximal portion is coated with polytetrafluoroethylene (PTFE). Through internal inspection process, the firm determined that Fathom guidewires from affected lots may exhibit a Pk number procode

Adverse-event reports — MAUDE (63)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

Malfunction: 44 · Injury: 19

12342019-01: 0 reports for this device; peer average 1.64/device2019-02: 1 reports for this device; peer average 1.52/device2019-03: 1 reports for this device; peer average 1.78/device2019-04: 0 reports for this device; peer average 1.69/device2019-05: 0 reports for this device; peer average 1.69/device2019-06: 0 reports for this device; peer average 1.57/device2019-07: 0 reports for this device; peer average 2.02/device2019-08: 0 reports for this device; peer average 2.38/device2019-09: 0 reports for this device; peer average 2.08/device2019-10: 0 reports for this device; peer average 2.24/device2019-11: 1 reports for this device; peer average 2.03/device2019-12: 0 reports for this device; peer average 2.52/device2020-01: 0 reports for this device; peer average 2.3/device2020-02: 4 reports for this device; peer average 2.95/device2020-03: 1 reports for this device; peer average 2.85/device2020-04: 0 reports for this device; peer average 2.16/device2020-05: 0 reports for this device; peer average 2.68/device2020-06: 0 reports for this device; peer average 2.49/device2020-07: 2 reports for this device; peer average 2.84/device2020-08: 1 reports for this device; peer average 2.54/device2020-09: 0 reports for this device; peer average 2.44/device2020-10: 0 reports for this device; peer average 2.65/device2020-11: 2 reports for this device; peer average 2.68/device2020-12: 2 reports for this device; peer average 2.75/device2021-01: 0 reports for this device; peer average 3.03/device2021-02: 0 reports for this device; peer average 2.16/device2021-03: 0 reports for this device; peer average 2.69/device2021-04: 1 reports for this device; peer average 2.62/device2021-05: 2 reports for this device; peer average 2.05/device2021-06: 3 reports for this device; peer average 2.42/device2021-07: 1 reports for this device; peer average 3.07/device2021-08: 3 reports for this device; peer average 2.39/device2021-09: 1 reports for this device; peer average 2.41/device2021-10: 2 reports for this device; peer average 2.02/device2021-11: 1 reports for this device; peer average 2.34/device2021-12: 1 reports for this device; peer average 2.64/device2022-01: 2 reports for this device; peer average 2.63/device2022-02: 0 reports for this device; peer average 2.35/device2022-03: 2 reports for this device; peer average 2.36/device2022-04: 1 reports for this device; peer average 2.61/device2022-05: 0 reports for this device; peer average 2.86/device2022-06: 2 reports for this device; peer average 2.75/device2022-07: 0 reports for this device; peer average 2.57/device2022-08: 0 reports for this device; peer average 3.01/device2022-09: 0 reports for this device; peer average 2.56/device2022-10: 0 reports for this device; peer average 2.26/device2022-11: 0 reports for this device; peer average 2.62/device2022-12: 2 reports for this device; peer average 2.42/device2023-01: 1 reports for this device; peer average 1.86/device2023-02: 0 reports for this device; peer average 2.64/device2023-03: 0 reports for this device; peer average 2.56/device2023-04: 1 reports for this device; peer average 2.25/device2023-05: 0 reports for this device; peer average 2.99/device2023-06: 0 reports for this device; peer average 2.39/device2023-07: 1 reports for this device; peer average 2.63/device2023-08: 0 reports for this device; peer average 2.65/device2023-09: 0 reports for this device; peer average 2.76/device2023-10: 2 reports for this device; peer average 2.54/device2023-11: 0 reports for this device; peer average 2.64/device2023-12: 1 reports for this device; peer average 2.8/device2024-01: 3 reports for this device; peer average 2.65/device2024-02: 1 reports for this device; peer average 2.63/device2024-03: 1 reports for this device; peer average 2.81/device2024-04: 1 reports for this device; peer average 2.26/device2024-05: 0 reports for this device; peer average 3.29/device2024-06: 2 reports for this device; peer average 3.05/device2024-07: 2 reports for this device; peer average 2.31/device2024-08: 1 reports for this device; peer average 3.62/device2024-09: 1 reports for this device; peer average 3.04/device2024-10: 0 reports for this device; peer average 4.01/device2024-11: 0 reports for this device; peer average 3.37/device2024-12: 0 reports for this device; peer average 3.81/device2025-01: 2 reports for this device; peer average 2.98/device2025-02: 0 reports for this device; peer average 3.19/device2025-03: 1 reports for this device; peer average 3.22/device2025-04: 0 reports for this device; peer average 3.49/device2025-05: 0 reports for this device; peer average 3.33/device2025-06: 0 reports for this device; peer average 2.89/device2025-07: 1 reports for this device; peer average 3.12/device2025-08: 0 reports for this device; peer average 3.21/device2025-09: 0 reports for this device; peer average 3.5/device2025-10: 1 reports for this device; peer average 3.24/device2025-11: 0 reports for this device; peer average 3.94/device2025-12: 0 reports for this device; peer average 4.49/device2026-01: 0 reports for this device; peer average 3.58/device2026-02: 0 reports for this device; peer average 3.79/device2026-03: 0 reports for this device; peer average 3.9/device2026-04: 0 reports for this device; peer average 2.99/device2026-05: 1 reports for this device; peer average 2.69/device2026-06: 0 reports for this device; peer average 2.84/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.64
2019-0211.52
2019-0311.78
2019-0401.69
2019-0501.69
2019-0601.57
2019-0702.02
2019-0802.38
2019-0902.08
2019-1002.24
2019-1112.03
2019-1202.52
2020-0102.3
2020-0242.95
2020-0312.85
2020-0402.16
2020-0502.68
2020-0602.49
2020-0722.84
2020-0812.54
2020-0902.44
2020-1002.65
2020-1122.68
2020-1222.75
2021-0103.03
2021-0202.16
2021-0302.69
2021-0412.62
2021-0522.05
2021-0632.42
2021-0713.07
2021-0832.39
2021-0912.41
2021-1022.02
2021-1112.34
2021-1212.64
2022-0122.63
2022-0202.35
2022-0322.36
2022-0412.61
2022-0502.86
2022-0622.75
2022-0702.57
2022-0803.01
2022-0902.56
2022-1002.26
2022-1102.62
2022-1222.42
2023-0111.86
2023-0202.64
2023-0302.56
2023-0412.25
2023-0502.99
2023-0602.39
2023-0712.63
2023-0802.65
2023-0902.76
2023-1022.54
2023-1102.64
2023-1212.8
2024-0132.65
2024-0212.63
2024-0312.81
2024-0412.26
2024-0503.29
2024-0623.05
2024-0722.31
2024-0813.62
2024-0913.04
2024-1004.01
2024-1103.37
2024-1203.81
2025-0122.98
2025-0203.19
2025-0313.22
2025-0403.49
2025-0503.33
2025-0602.89
2025-0713.12
2025-0803.21
2025-0903.5
2025-1013.24
2025-1103.94
2025-1204.49
2026-0103.58
2026-0203.79
2026-0303.9
2026-0402.99
2026-0512.69
2026-0602.84
This device (reports/month)Average device in DQX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K053268 — cited as predicate by K190843, K202522, K222690

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Stryker Corporation

  • Warning Letter 2017-04-06 Entellus Medical Inc.
  • Warning Letter 2015-04-08 Thermedx LLC
  • Injunction 2013-11-26 Physio-Control, Inc.
  • Warning Letter 2013-03-06 Stryker Corporation
  • Warning Letter 2013-03-06 Stryker Corporation
  • NAI 2026-06-18 International Life Sciences · 0 citations
  • VAI 2026-02-20 Stryker Puerto Rico, LLC · 2 citations
  • NAI 2025-12-11 Stryker Manufacturing Kalamazoo · 0 citations
  • NAI 2025-05-22 Stryker Macroom · 0 citations
  • VAI 2025-03-27 Stryker GmbH · 1 citations
  • VAI 2025-03-27 Stryker GmbH · 1 citations
  • NAI 2025-02-27 Stryker Leibinger GmbH & Co. KG · 0 citations
  • NAI 2025-01-30 Serf · 0 citations
  • VAI 2024-12-18 Stryker Neurovascular · 1 citations
  • VAI 2024-11-15 Stryker Medical Division of Stryker Corporation · 2 citations
  • NAI 2024-11-13 POM Medical LLC · 0 citations
  • VAI 2024-07-25 Stryker Ireland, Ltd., Instruments Division · 1 citations
  • NAI 2024-05-03 Stryker Neurovascular, Inc. · 0 citations
  • NAI 2024-04-18 Physio-Control, Inc. · 0 citations
  • VAI 2023-12-01 Howmedica Osteonics Corp. · 1 citations
  • VAI 2023-05-15 LimFlow, Inc. · 2 citations
  • NAI 2023-04-25 Stryker Puerto Rico, LLC · 0 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2022-03-08 POM Medical LLC · 0 citations