Synchro SELECT SSTD300PRERecalls & reported problems
Stryker Corporation · STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327508529), received between Oct 28, 2021 and Oct 28, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Peeled/Delaminated” (1 report).
1 other recall cover devices cleared under the same FDA submission (K202522); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2021Peeled/Delaminated; Peeled/Delaminated
ANALYSIS OF THE RETURNED DEVICE FOUND THE SUBJECT GUIDEWIRE PTFE COATING WAS PEELING/PEELED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12712707 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K202522. One submission often covers many models, so check the product and lot details in each record.
- Z-1940-2024 · Apr 18, 2024 · Open, ClassifiedThe Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires a
Other Guide, wire, catheter, neurovasculature devices
- Synchro SELECT SSTD215STRStryker Corporation · Guide, wire, catheter, neurovasculature1 recall97 reports
- Synchro SELECT SSTD215PREStryker Corporation · Guide, wire, catheter, neurovasculature1 recall16 reports
- Synchro SELECT SSUP215PREStryker Corporation · Guide, wire, catheter, neurovasculature1 recall11 reports
- Synchro2 S2SPS14300Stryker Corporation · GUIDE, WIRE, CATHETER, NEUROVASCULATURE1 recall1 death6 reports
- Synchro SELECT SSUP300STRStryker Corporation · Guide, wire, catheter, neurovasculature1 recall5 reports
- Synchro2 S2SPP14300Stryker Corporation · GUIDE, WIRE, CATHETER, NEUROVASCULATURE1 recall2 reports
- Synchro SELECT SSFT300STRStryker Corporation · Guide, wire, catheter, neurovasculature1 recall0 reports
- Mirage 103-0608Micro Therapeutics, Inc. · Guide, wire, catheter, neurovasculature12 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.