Z-0065-2020Class II

Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI...

Name: Z-0065-2020 Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI...
Creator: Stryker Neurovascular
Published: 2018-11-13
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2018-11-13 / Terminated / root cause: labeling and UDI

FDA source

Stryker Neurovascular began a recall of Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771 on 2018-11-13. FDA classified it as Class II and gives the reason as "Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0065-2020
Classification: Class II
Status: Terminated
Initiated: 2018-11-13
Posted: 2019-10-08
Terminated: 2020-08-03
Recalling firm: Stryker Corp.
Product: Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771
Product code: DQY Catheter, Percutaneous
Reason for recall: Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: On 11/13/2018, a "Urgent Medical Device Voluntary Field Corrective Action" letter was sent to all affected consignees. Per the customer notification letter, it informed customers of the following: 1. Immediately check your internal inventory for 9F BGC Lot 0000010779. 2. Circulate this Customer Communication internally to all interested/affected parties. 3. If the specified lot is located, open the carton and remove the pouch. Without removing the device from the pouch or breaking the sterile barrier, inspect the device through the pouch and confirm that the text on the white strain relief reads 9F/.085 ID (shown in Fig. 1). If confirmed, no further action is needed to be taken for this device. 4. If the device identified above reads 8F/.078 ID (shown in Fig. 2) please discard the device and take note of this in the comments section in the attached response form. 5. On receipt of this form, replacement product will be issued to you. If you require assistance in executing these steps, please reach out to your Stryker sales representative. 6. Inform Stryker if any of the subject devices have been distributed to other organizations and provide Stryker the contact information for these organizations. 7. Please inform Stryker of any adverse events concerning the use of the subject devices. 8. Return the completed form to [email protected]. 9. We request that you respond to this notice within 7 calendar days from the date of receipt. The target date for completion of this action is 31 Jan 2019 and your timely response will enable us to ensure that we meet this target.
Quantity in commerce: 190 catheter guides
Distribution: OUS distribution only: CZECH REPUBLIC, ITALIA, Netherlands, Sweden, Germany, Austria, Israel, France, Belgium, Finland, Switzerland, Portugal, Finland
Product codes and lots: Lot number 0000010779; This lot was not distributed within the US

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0065-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0065-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-08

Product code DQY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)