DAC 070 90771Recalls & 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 07613327313963), received between Sep 27, 2021 and Sep 27, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
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.
MalfunctionSep 27, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING AN ACUTE THROMBECTOMY TREATMENT, THE SUBJECT DISTAL ACCESS CATHETER (DAC) WAS USED ALONG WITH A MICROCATHETER ENCOUNTERED DIFFICULTY ADVANCING IN THE GUIDING CATHETER. THE OPERATOR WITHDREW THE WHOLE SYSTEM, AND NOTICED BIG RESISTANCE BETWEEN THE SUBJECT CATHETER AND THE GUIDING CATHETER. IT WAS ALSO REPORTED THAT THE TIP OF THE CATHETER (SUBJECT DEVICE) WAS FRACTURED. THE PATIENT'S ANATOMY WAS REPORTED AS MODERATELY TORTUOUS. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND COMPLETE THE PROCEDURE SUCCESSFULLY. 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 12536374 ↗
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
Other CATHETER, PERCUTANEOUS devices
- WATCHMAN FXD Curve™ Access System M635TU80020Boston Scientific Corporation · Catheter, percutaneous1 recall47 deaths654 reports
- NA C315HIS02Medtronic, Inc. · Catheter, percutaneous1 recall369 reports
- WATCHMAN TruSteer™ Access System M635TU90050Boston Scientific Corporation · Catheter, percutaneous1 recall28 deaths302 reports
- Guidezilla™ II H7493933515060Boston Scientific Corporation · CATHETER, PERCUTANEOUS1 recall3 deaths278 reports
- Velocity Delivery Microcatheter VEL160STR-APenumbra, Inc. · CATHETER, PERCUTANEOUS297 reports
- Guidezilla™ H7493924215050Boston Scientific Corporation · CATHETER, PERCUTANEOUS294 reports
- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 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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