—#176254

Product

Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K010954, K112404
Affected lot / code info: Lot number 0000010779; This lot was not distributed within the US

Why it was recalled

Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

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 NVFieldActions@stryker.com. 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.

Recalling firm

Firm: Stryker Neurovascular
Address: 47900 Bayside Pkwy, Fremont, California 94538-6515

Distribution

Distribution pattern: OUS distribution only: CZECH REPUBLIC, ITALIA, Netherlands, Sweden, Germany, Austria, Israel, France, Belgium, Finland, Switzerland, Portugal, Finland

Timeline

Recall initiated: 2018-11-13
Terminated: 2020-08-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176254. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.