Stryker Neurovascular recalls The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end…
Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed…
Read the official notice →- Date
- 2024-10-16
- Country
- United States
- Brand
- Stryker Neurovascular
- Product
- The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end…
- Classification
- Class II
- Units
- U.S. Nationwide distribution in the states of CA and VA.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Stryker Neurovascular recalls
- 2026-07-01
US
Stryker Neurovascular recalls INZONE DETACHMENT SYSTEM, REF: M00345100950
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended,…
FDA · DeviceStryker NeurovascularWorldwide - US Nationwide distribution including in the states of PA, AZ, FL,…Official notice →- 2024-06-12
US
Stryker Neurovascular recalls The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The…
Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer…
FDA · DeviceStryker NeurovascularWorldwide - US Nationwide distribution including in the states of TX, NY, MD,…Official notice →- 2024-06-05
US
Stryker Neurovascular recalls Trevo ProVue, Catalog: 90184
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable…
FDA · DeviceStryker NeurovascularWorldwide - US Nationwide distribution including in the states of MN, PA, IL,…Official notice →- 2024-05-08
US
Stryker Neurovascular recalls The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a…
Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification…
FDA · DeviceStryker NeurovascularUS Nationwide distribution in the states of TX, FL, NJ, CO, LA, NC, AL, PA,…Official notice →- 2022-07-27
US
Stryker Neurovascular recalls Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413;…
Microcatheter product label on the carton is missing the microcatheter product drawing/illustration.
FDA · DeviceStryker NeurovascularWorldwide distribution - US Nationwide distribution in the states of CA, OR,…Official notice →
Other drugs & medical recalls in the United States
- 2024-10-16
US
Atrium Medical Corporation recalls iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
FDA · DeviceAtrium Medical CorporationUS Nationwide distribution in the states of FL, MA, MI, OH, WA.Official notice →US
Howmedica Osteonics Corp. recalls Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and…
Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.
FDA · DeviceHowmedica Osteonics Corp.US Nationwide distribution in the states of AZ, FL, NC, OH, PA, TN, WI.…Official notice →US
Qualigen Inc recalls FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher than expected.
FDA · DeviceQualigen IncUS: TX, MS, NY, OH, MT, WA, PA, MN, SC, GA, NC, NV, WY, AK, SD, KS, NE, VT,…Official notice →US
Philips North America Llc recalls IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows:…
Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices.…
FDA · DevicePhilips North America LlcForeign Only: Denmark France Germany Japan United KingdomOfficial notice →US
Zyno Medical LLC recalls Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and…
There is a defect in the air-in-line software algorithm.
US
123Herbals recalls Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru,…
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.