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VNS Therapy PerenniaDURA Model 303 Lead recallZ-0532-2022 · LivaNova USA, Inc. · initiated Dec 2, 2021

Terminated

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 LivaNova USA, 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

A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less than the design specification. If the tubing becomes completely breached, the patient may experience discomfort or pain due to delivery of stimulation to an unintended location. If the inner lead conductor is exposed to body fluids the lead may break causing loss of therapy.

FDA root cause category: Process change control

What the company is doing

On 12/02/21, Liva Nova initiated a verbal notification to hospital consignees. Hospitals were asked to remove affected devices from inventory. On 12/17/21, a removal notice was distributed to consignees who were asked to take the following actions: 1. Remove affected devices from your hospital/facility s inventory. 2. Recalling firm will contact you to coordinate removal and replacement of these devices. 4. If affected devices have been implanted, please notify your local representative as soon as possible. A medical device correction notice was sent to doctors managing patients with implanted affected devices were asked to take the following actions: 1. Ask the patient to report any changes in the comfort or perception of their stimulation therapy. 2. Advise patients to use their magnet daily (epilepsy indication only) to verify that stimulation is felt, and to report any change in perceived clinical symptoms related to stimulation. An inability to feel stimulation or changes in clinical symptoms may be an early indicator of a lead break (e.g., increase in seizures, painful stimulation, or changes in the perception of stimulation might indicate a lead break). 3. At each office visit, including those scheduled due to changes reported by patient for items 1 or 2 above, interrogate the device and run device system diagnostics . If diagnostics suggest that a lead fracture is present, program the VNS generator to 0mA Please ensure this notice is communicated to all personnel within your organization who need to be aware of it. This action is being reported to the Food and Drug Administration. For questions customers can contact the recalling firm at: +1 (281) 228-7330 (Monday to Friday, 8 AM to 5 PM CST) or e-mail at [email protected].

Recall details

Recall number
Z-0532-2022
Status
Terminated
Initiated by the company
Dec 2, 2021
Recalling firm
LivaNova USA, Inc.
Quantity
10
Product code
LYJ
FDA submissions
P970003
Distribution
US: NE, MO, AR, WV, KS, MA, IN

Product description

Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter)

Code information (models, lots, serial numbers)

UDI: 05425025750115. Serial Numbers: 119441, 119442, 119443, 119452, 119453, 119454, 119455, 119456, 119457, 119458

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

22 devices cleared under P970003 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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