The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0567-2013·Announced 2012-12-26

Medtronic Recalls 140 DBS Extension Kits with Damaged Connector Boots

Medtronic is recalling 140 Deep Brain Stimulation Extension Kits because the connector boots may be cracked or improperly molded.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: The recall involves a medical device with a structural defect (cracked connector boot) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Medtronic is recalling 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086). The recall was initiated because the kits may contain a damaged winged connector boot. The connector boot may not have been molded properly and may be cracked.

Approximately 14% of the 140 affected extension kits may contain a damaged radiopaque winged connector boot. The affected products are distributed worldwide, including in the United States and several countries in Europe and Asia.

Patients and healthcare providers should contact Medtronic for further instructions regarding the recall and potential replacement of the affected extension kits.

The recalled product

Product
Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Rico. Medtronic¿ DBSTM Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the…
Manufacturer
Medtronic Neuromodulation
Category
Medical Device — Neurostimulation
Hazard
Affected units
140

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 (8)

  • NHU236350V to NHU236373V
  • NKN037257V to NKN037259V
  • NKN037372V to NKN037387V
  • NKN037476V to NKN037507V
  • NKN037692V to NKN037698V
  • NKN037772V to NKN037779V
  • NKN037790V to NKN037810V
  • NKN037812V to NKN037840V.

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

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