Stryker Neurovascular INZONE Detachment System battery drain
Stryker Neurovascular is recalling the INZONE Detachment System (REF: M00345100950) due to premature battery drain that may prevent the device from powering on or detaching coils as intended.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a risk-of-harm device (inability to detach coil may necessitate medical intervention) where no illnesses or injuries are reported in the source text. This meets the High severity criterion for risk-of-harm products without reported injury.
Plain-English summary
Stryker Neurovascular is recalling 44,937 units of the INZONE Detachment System, model reference M00345100950, distributed worldwide. The device may experience premature battery drain.
This battery drain can cause the device to fail to power on, power on with faint audible and visual indicators, or be unable to detach a coil as intended. If the coil cannot be detached during a procedure, medical intervention may be necessary to complete the procedure using an alternative technique.
The affected product was distributed internationally and across US states including Pennsylvania, Arizona, Florida, California, Illinois, Alaska, New York, Michigan, New Jersey, Wisconsin, South Dakota, Kentucky, Arkansas, Texas, Alabama, Tennessee, Missouri, Massachusetts, Indiana, Nebraska, West Virginia, Montana, Connecticut, North Carolina, Virginia, Nevada, Colorado, Washington DC, Delaware, Ohio, Maine, Georgia, Washington, South Carolina, Guam, Minnesota, Oklahoma, New Hampshire, Maryland, North Dakota, Utah, Hawaii, Oregon, Louisiana, Mississippi, Kansas, New Mexico, Idaho, Iowa, and Vermont.
Patients and healthcare providers should contact Stryker Neurovascular regarding this recall. Affected lot numbers include WMP133638, WMP133871, WMP133872, WMP133988, WMP133989, WMP134016, WMP134132, WMP134133, WMP134234, WMP134235, WMP134255, WMP134256, WMP134380, WMP134381, WMP134432, WMP134433, WMP134518, WMP134519, WMP134609, WMP134610, WMP134794, WMP134795, WMP134939, WMP134940, WMP135187, WMP135243, WMP135302, WMP135314, WMP135354, WMP135355, WMP135387, WMP135417, WMP135473, WMP135475, WMP135491, WMP135492, WMP135623, WMP135720, WMP135727, WMP135807, WMP135865, WMP135897, WMP136084, WMP136107, WMP136190, WMP136200, WMP136611, WMP136642, WMP136736, WMP136748, WMP136852, WMP136894, and WMP136985.
The recalled product
- Product
- INZONE DETACHMENT SYSTEM, REF: M00345100950
- Manufacturer
- Stryker Neurovascular
- Affected units
- 44,937
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 04546540697950. Lots: WMP133638
- WMP133871
- WMP133872
- WMP133988
- WMP133989
- WMP134016
- WMP134132
- WMP134133
- WMP134234
- WMP134235
- WMP134255
- WMP134256
- WMP134380
- WMP134381
- WMP134432
- WMP134433
- WMP134518
- WMP134519
- WMP134609
- WMP134610
Distribution
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