Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scie...
FDA Device Recall #Z-2459-2012 — Class II — September 6, 2012
Recall Summary
| Recall Number | Z-2459-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 6, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Greatbatch Medical |
| Location | Minneapolis, MN |
| Product Type | Devices |
| Quantity | 787 |
Product Description
Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441. To facilitate transvenous introduction of diagnostic / therapeutic catheters into the vasculature and into the chambers of the heart.
Reason for Recall
During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardiac cryoablation balloon catheters, the internal PTFE sheath liners were found to display varying degrees of damage that could pose an embolic risk to a patient.
Distribution Pattern
Distributed in MA.
Lot / Code Information
Q2112752, Q2110939, Q2130137, Q2131250, Q2130212, Q2150143, W2162515, W2163769, W2160626, W2175891, W2172722, W2184492, W2196366, W2184490, W2205843
Other Recalls from Greatbatch Medical
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2055-2017 | Class II | Linear Straight Broach Handle (Rasp Handle) (Gr... | Apr 23, 2017 |
| Z-2782-2017 | Class II | Biosense Webster MobiCath Bi-Directional Guidin... | Feb 15, 2017 |
| Z-2781-2017 | Class II | ViaPeel PTFE Peelable Introducer 5FR, Part Numb... | Nov 11, 2016 |
| Z-1190-2017 | Class II | Offset Reamer Handle, T5766 Product Usage: ... | Oct 19, 2016 |
| Z-0623-2017 | Class II | Greatbatch Stiffer Coaxial Micro-Introducer. Mo... | Sep 8, 2016 |
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.