Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use...
FDA Device Recall #Z-2613-2016 — Class II — April 15, 2016
Recall Summary
| Recall Number | Z-2613-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 15, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cook Inc. |
| Location | Bloomington, IN |
| Product Type | Devices |
| Quantity | 60,302 |
Product Description
Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques
Reason for Recall
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
Distribution Pattern
Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.
Lot / Code Information
All Lots. Catalog prefixes/suffixes SCBR5.5-/-SHTL SCBR6.5-/-SHTL Catalog/product number; Global/order number SCBR5.5-35-125-P-NS-H1-SHTL G31129 SCBR5.5-35-125-P-NS-JB1-SHTL G31130 SCBR5.5-35-125-P-NS-JB2-SHTL G36361 SCBR5.5-35-125-P-NS-MPA-SHTL G23697 SCBR5.5-35-125-P-NS-SIM1-SHTL G23699 SCBR5.5-35-125-P-NS-SIM2-SHTL G36360 SCBR5.5-35-125-P-NS-VERT-SHTL G23698 SCBR5.5-35-125-P-NS-VTK-SHTL G36359 SCBR5.5-35-135-P-NS-ANG-SHTL G48154 SCBR5.5-35-150-P-NS-0-SHTL G23705 SCBR5.5-35-150-P-NS-ANG-SHTL G23704 SCBR5.5-35-75-P-NS-ANG-SHTL G48152 SCBR6.5-35-125-P-NS-H1-SHTL G31134 SCBR6.5-35-125-P-NS-JB1-SHTL G31135 SCBR6.5-35-125-P-NS-JB2-SHTL G36364 SCBR6.5-35-125-P-NS-SIM1-SHTL G23701 SCBR6.5-35-125-P-NS-SIM2-SHTL G36363 SCBR6.5-35-125-P-NS-VERT-SHTL G23700 SCBR6.5-35-125-P-NS-VTK-SHTL G36362
Other Recalls from Cook Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0388-2022 | Class II | Flexor Check-Flo Introducer Ansel Modification ... | Nov 12, 2021 |
| Z-0387-2022 | Class II | Flexor Check-Flo Introducer Ansel Modificatio... | Nov 12, 2021 |
| Z-0414-2022 | Class II | Skinny Needle with Chiba Tip. RPN 090010, 09001... | Oct 13, 2021 |
| Z-0222-2022 | Class II | Transseptal Needle, Trocar. RPN TSNC-18-71.0, T... | Oct 8, 2021 |
| Z-0223-2022 | Class II | Transseptal Needle with Catheter. RPN TSN-17-75... | Oct 8, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.