DAC 070 90770Recalls & 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 07613327313932), received between Dec 18, 2018 and Dec 18, 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.
MalfunctionDec 18, 2018Break; Break
IT WAS REPORTED THAT DURING INNOMINATE ARTERY STENOSIS (IAS) OCCLUSION CASE, THE DISTAL OF THE SUBJECT DEVICE WAS FOUND TO BE BROKEN AFTER REACHING THE PLACE AND DID ASPIRATION. SO THE OPERATOR REPLACED IT WITH OTHER CATHETER TO FINISH THE PROCEDURE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8177548 ↗
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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- Trevo 90238Stryker Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls5 reports
- Expo™ H749085263011Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls3 reports
- 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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