Distal Access Catheters - 044 - 115 cm recallZ-0116-2016 · Concentric Medical Inc · initiated Aug 19, 2015
Class II Terminated All recalls posted in October 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Concentric Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
One Distal Access Catheter intended for distribution in Korea, was found at a US location.
FDA root cause category: Employee error
What the company is doing
Issue was discovered by a sales representative during a visit for a case in Kentucky, where multiple Distal Access Catheters (DAC's) were being used. It was noticed that the reference number on one DAC carton did not match, even through the product labeling appeared to be the same. The mismatched unit was removed and returned to Concentric (Stryker). A formal recall letter was not issued as the product was returned after discovery. For further questions please call (510) 413-2263.
Recall details
- Recall number
- Z-0116-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 19, 2015
- Posted by the FDA
- Oct 9, 2015
- Recalling firm
- Concentric Medical Inc
- Quantity
- 1
- Product code
- DQY
- FDA submissions
- K133177
- Distribution
- US Distribution to one location in KY.
Product description
Distal 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 guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.
Code information (models, lots, serial numbers)
Lot no. 37603 Expiration date: September 2016
Other devices under the same FDA submission
5 devices cleared under K133177 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- DAC 044 90760Stryker Corporation · CATHETER, PERCUTANEOUS1 recall2 reports
- DAC 038 90721Stryker Corporation · CATHETER, PERCUTANEOUS1 recall0 reports
- DAC 070 90770Stryker Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- DAC 057 90731Stryker Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- DAC 070 90771Stryker Corporation · CATHETER, PERCUTANEOUS1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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