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Synchro SELECT
Model SSUP215PRE · Stryker Corporation · DI 07613327508635
DQX — Wire, Guide, Catheter · Class II · 21 CFR 870.1330
MOF — Guide, Wire, Catheter, Neurovasculature · Class II · 21 CFR 870.1330
UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2024-04-18
Z-1940-2024
Class II
Open, Classified
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.
code info di
Adverse-event reports — MAUDE (11)
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: 7 · Injury: 4
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
1.64
2019-02
0
1.52
2019-03
0
1.76
2019-04
0
1.69
2019-05
0
1.69
2019-06
0
1.55
2019-07
0
2.02
2019-08
0
2.38
2019-09
0
2.08
2019-10
0
2.24
2019-11
0
2.03
2019-12
0
2.52
2020-01
0
2.27
2020-02
0
2.9
2020-03
0
2.85
2020-04
0
2.16
2020-05
0
2.68
2020-06
0
2.46
2020-07
0
2.83
2020-08
0
2.54
2020-09
0
2.39
2020-10
0
2.62
2020-11
0
2.65
2020-12
0
2.71
2021-01
0
3
2021-02
0
2.12
2021-03
0
2.65
2021-04
0
2.6
2021-05
0
2.02
2021-06
0
2.4
2021-07
0
2.95
2021-08
0
2.36
2021-09
0
2.32
2021-10
0
1.97
2021-11
0
2.33
2021-12
0
2.59
2022-01
0
2.58
2022-02
0
2.37
2022-03
0
2.41
2022-04
0
2.51
2022-05
0
2.78
2022-06
0
2.69
2022-07
0
2.47
2022-08
0
2.92
2022-09
0
2.5
2022-10
1
2.18
2022-11
0
2.58
2022-12
0
2.33
2023-01
0
1.86
2023-02
0
2.53
2023-03
0
2.51
2023-04
0
2.18
2023-05
1
2.87
2023-06
0
2.34
2023-07
0
2.57
2023-08
0
2.62
2023-09
0
2.63
2023-10
0
2.51
2023-11
0
2.55
2023-12
2
2.68
2024-01
1
2.57
2024-02
0
2.6
2024-03
0
2.76
2024-04
0
2.2
2024-05
0
3.17
2024-06
0
2.94
2024-07
0
2.24
2024-08
0
3.44
2024-09
0
2.96
2024-10
0
3.8
2024-11
0
3.29
2024-12
0
3.67
2025-01
0
2.94
2025-02
0
3.07
2025-03
1
3.1
2025-04
0
3.32
2025-05
1
3.15
2025-06
0
2.88
2025-07
0
2.97
2025-08
1
3.12
2025-09
0
3.33
2025-10
0
3.11
2025-11
0
3.84
2025-12
0
4.14
2026-01
1
3.52
2026-02
1
3.82
2026-03
1
3.83
2026-04
0
2.94
2026-05
0
2.6
2026-06
0
2.77
This device (reports/month)Average device in DQX, MOF (reports/device/month)