The battery fails mid-procedure — what being unable to detach a coil means
Stryker Neurovascular reported that its embolization coil detachment devices may drain their batteries early, leaving them unable to power on, powering on with faint indicators, or unable to detach a coil as intended.
Recall overview (primary data)
- ClassificationClass II
- Product typeMedical Device
- Recalling firmStryker Neurovascular
- ReasonEmbolization 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, which may necessitate medical intervention if the procedure must be completed with an alternative technique.
- DistributionWorldwide - US Nationwide distribution including in the states of PA, AZ, FL, CA, IL, AK, NY, MI, NJ, WI, SD, KY, AR, TX, AL, TN, MO, MA, IN, NE, WV, MT, CT, NC, VA, NV, CO, DC, DE, OH, ME, GA, WA, SC...
- Recall initiated2026-04-06
Key points
- The product is the INZONE Detachment System, reference M00345100950, an embolization coil detachment system.
- Premature battery drain may leave devices unable to power on, powering on with faint audible and visual indicators, or unable to detach a coil as intended.
- Where a coil cannot be detached, medical intervention may be needed if the procedure must be completed by an alternative technique.
- The recalling firm is Stryker Neurovascular, the quantity 44,937 units, distributed across all 50 states and 53 further countries and territories.
- The recall began on 6 April 2026 and was reported on 1 July, a gap of 86 days.
1When a fault shows itself bears on the class
The three records so far had their problems appear before use or after it. Not this one. The fault can appear in the middle of a procedure. Embolization coils are used in treating cerebral vessels among other things, and a detachment system is what releases the coil at the intended position.
2Three symptoms
- 1Fails to power onNoticed before use; another device can be taken instead
- 2Powers on with faint indicatorsStarts up with weak audible and visual signals, so the fault is harder to spot
- 3Cannot detach the coilDiscovered mid-procedure, with the coil not released where intended
- 4What followsMedical intervention may be needed where the procedure must be completed by an alternative technique
The three do not weigh the same. A device that will not power on is caught before anything begins. The third, though, becomes apparent once the device is already inside the body. The later the fault is noticed, the fewer the moves remaining.
3Class II all the same
The record says medical intervention may be needed if the procedure must be completed with an alternative technique. It does not say the procedure cannot be completed. Intervention becomes necessary, but a way through remains, and that margin reads as the ground for staying at Class II.
4The scale
Eighty-six days passed between the recall beginning and its report, against a median of 47 across the unpublished records. A recall of this quantity and reach presumably takes longer to identify and notify, though the record offers no reason.
Why it matters
For the same device fault, when it can be noticed changes what remains possible. Caught before use, another device can be substituted; discovered mid-procedure, the options narrow. The ground for staying at Class II reads from the record itself, which speaks of completing the procedure by an alternative technique rather than of being unable to complete it at all.
FAQ
Why do the three symptoms differ in weight?
Why is this Class II?
Is 86 days to report a long time?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: Z-2552-2026