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,…
Read the official notice →- Date
- 2026-07-01
- Country
- United States
- Brand
- Stryker Neurovascular
- Product
- INZONE DETACHMENT SYSTEM, REF: M00345100950
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of PA, AZ, FL,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-10-16
USStryker 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…
FDA · DeviceStryker NeurovascularU.S. Nationwide distribution in the states of CA and VA.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
- 2026-07-01
- US
SURGIFY MEDICAL OY recalls Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA · DeviceSURGIFY MEDICAL OYUS Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Official notice → - US
IPG Medical Corporation recalls Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Software anomaly that causes a false display of error code 5018.
- US
GE Medical Systems SCS recalls GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g.…
FDA · DeviceGE Medical Systems SCSWorldwide distribution - United States Nationwide and the countries of…Official notice → - US
Acumed LLC recalls Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL Hexalobe Screw;…
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
FDA · DeviceAcumed LLCUS Nationwide distribution in the states of AR, CA, CO, CT, FL, GA, IL, KS,…Official notice → - US
Zimmer, Inc. recalls Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
- US
PFM MEDICAL INC. recalls Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with…