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…
Read the official notice →- Date
- 2024-05-08
- Country
- United States
- Brand
- Stryker Neurovascular
- Product
- The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of TX, FL, NJ, CO, LA, NC, AL, PA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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USStryker 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 →- 2024-10-16
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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…
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 → - 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
- 2024-05-08
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SEDECAL SA recalls Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt;…
Potential interference with the anti-fall system.
FDA · DeviceSEDECAL SAWorldwide distribution - US Nationwide in the states of CA, IL, NJ, and areas…Official notice → - US
Innomed, Inc. recalls INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.
FDA · DeviceInnomed, Inc.FL, GA, PA, NY, CA, VA, SD, MN, TX, UT, NC, and UK, Denmark, Germany…Official notice → - US
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Potential for reported SSD to be too high.
FDA · DeviceRAYSEARCH LABORATORIES ABWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - US
Cardinal Health 200, LLC recalls Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
FDA · DeviceCardinal Health 200, LLCWorldwide distribution - US Nationwide and the countries of Panama, Guatemala,…Official notice → - US
Noah Medical recalls Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide…
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