HIGHFDA DEVICE

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, which may necessitate medical intervention if the procedure must be completed with an alternative technique.

Stryker NeurovascularHealth & Personal CareMedical DevicesUDI-DI: 04546540697950. Lots: WMP133638WMP133871WMP133872

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
April 6, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
April 6, 2026
Hazard Level
HIGH
Brand
Stryker Neurovascular
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Stryker Neurovascular
Model numbers
UDI-DI: 04546540697950. Lots: WMP133638, WMP133871, WMP133872, WMP133988, WMP133989, WMP134016, WMP134132, WMP134133 +12 more
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    April 6, 2026

  2. Reported by FDA DEVICE

    July 1, 2026

  3. RecallRadar source check

    July 7, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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, which may necessitate medical intervention if the procedure must be completed with an alternative technique.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Stryker Neurovascular or your healthcare provider for instructions. Notification method: N/A

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Full Description

INZONE DETACHMENT SYSTEM, REF: M00345100950. Reason: 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, which may necessitate medical intervention if the procedure must be completed with an alternative technique.. Classification: Class II. Quantity: 44,937. Distribution: Worldwide - 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, GU, MN, OK, NH, MD, ND, UT, HI, OR, LA, MS, KS, NM, ID, IA, VT and the countries of ARGENTINA, AUSTRIA, BELGIUM, BRASIL, BULGARIA, CANADA, CANARY ISLANDS, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, IRAN, IRELAND, ISRAEL, ITALIA, JAPAN, KOREA, LATVIA, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NORTHERN IRELAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH PACIFIC, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
UDI-DI: 04546540697950. Lots: WMP133638
WMP133871
WMP133872
WMP133988
WMP133989
+15 more
Affected States
ALL
Report Date
July 1, 2026
Recall Status
ACTIVE