The Recall Desk
HighFDA (Devices)·Z-0170-2023·Announced 2022-11-09

Aneurysm Embolization System Detachment Controller Recalled for Manufacturing Defect

MICROVENTION is recalling WEB Detachment Controllers due to an out-of-specification tunnel opening that may prevent proper implant detachment. This defect could delay treatment and cause vessel damage from implant manipulation.

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: This is a Class II medical device recall with no reported injuries or illnesses. The defect is a manufacturing error in a high-risk surgical device that could lead to serious consequences (vessel damage), but actual harm has not been documented. Per the rubric, risk-of-harm products without reported injury score at 3 (High).

Plain-English summary

MICROVENTION INC. is recalling the WEB Detachment Controller (model WDC-2, WDC, MV-WDC2), a component of the WEB Aneurysm Embolization System, due to a manufacturing defect affecting approximately 2,018 units worldwide.

The recalled detachment controller has an out-of-specification tunnel opening dimension that may prevent the implant device pusher from being fully inserted into the controller. This can result in the inability to properly detach the implant device during the procedure.

If the implant cannot be detached, physicians may need to apply excessive manipulation or delay the procedure, which could cause the implant to move and potentially damage blood vessels. This recall affects units distributed across the United States and internationally, including Japan, China, Argentina, Australia, South Korea, Italy, and the UK.

Patients who received treatment with these controllers should contact their healthcare provider. Physicians and medical facilities should cease use of affected lot numbers and report any adverse events to the FDA.

The recalled product

Product
WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
Manufacturer
MICROVENTION INC.
Category
Medical Device — Aneurysm Treatment
Hazard
  • manufacturing-defect
  • implant-dislodgment
  • vessel-damage

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)

  • REF/UDI/Lots: WDC-2/00842429103128/0000095683
  • 0000096284
  • 0000205967
  • 0000206629
  • 0000215962
  • 0000216862
  • 0000224074
  • 0000241662
  • 0000242343
  • 0000242345
  • Distributed in China: WDC/00842429113684/0000078840
  • 0000086571
  • 0000088347
  • 0000088349
  • 0000136477
  • 0000181460
  • 0000191147
  • Distribution in Japan: MV-WDC2/04987892122231/0000142172
  • 0000166445
  • 0000210109

Distribution

Distributed nationwide across the United States.

Related recalls

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