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WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2.… recallZ-0170-2023 · Microvention Inc. · initiated Sep 21, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Microvention Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into the controller, which may result in the inability of the controller to properly detach the implant device, which could cause delays and excessive manipulation that may cause the implant to move and damage vessels

FDA root cause category: Process control

What the company is doing

On 09/21/2022, recall notices were mailed to customers who were asked to do the following: 1) Identify, quarantine, and return all impacted devices. 2) Complete and return Customer Acknowledgment and Device Reconciliation form the recall instructions provided in the letter and have shared this notification with all device users within my facility and network to ensure they are aware of this recall. This recall notice should also be shared with any organization where the potentially affected devices have been transferred. Complete and return the acknowledgement and receipt form. Customers with additional questions can call the recalling firm at 949-501-0355, Monday - Friday PST 8:00 - 5:00 pm or email [email protected]

Recall details

Recall number
Z-0170-2023
Status
Open, Classified
Initiated by the company
Sep 21, 2022
Posted by the FDA
Nov 2, 2022
Recalling firm
Microvention Inc.
Quantity
2018
Product code
OPR
FDA submissions
P170032
Distribution
Worldwide - US Nationwide distribution in the states of MN, PA, NY, MI, FL, VA, TX, OH, CA, NE, MN, NC, LA, IL, TN, IN, UT, KS and the countries of Japan, China, Argentina, Australia, South Korea, Italy, UK.

Product description

WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.

Code information (models, lots, serial numbers)

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; 0000245337

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

43 devices cleared under P170032 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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