DAC 057 90731Recalls & reported problems
Stryker Corporation · Distal Access Catheter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 07613327313949), received between May 30, 2018 and May 30, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K133177); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2018Break; Break
ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL WAS BROKEN. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7555512 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K133177. One submission often covers many models, so check the product and lot details in each record.
- Z-1908-2024 · Apr 23, 2024 · Open, ClassifiedDAC 044 115cm, Catalog: 90760
- Z-1740-2024 · Apr 3, 2024 · Open, ClassifiedThe Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter s
- Z-0116-2016 · Aug 19, 2015 · TerminatedDistal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and g
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- Expo™ H74908526501Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls1 report
- Expo™ H74908526031Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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