CSF-Unitized Shunt, Contoured Regular, Low Pressure… recallZ-0397-2014 · Medtronic Neurosurgery · initiated Nov 18, 2013

Why it was recalled

Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.

FDA root cause category: Other

What the company is doing

Medtronic Neurosurgery sent an Urgent Medical Device Recall letter dated November 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to provide a copy of the letter to all those who need to be aware of the matter within their organization or to any organization where the potentially affected product may have been transferred. Customers with questions were instructed to call 805-571-8725.

Recall details

Recall number

Z-0397-2014

Recall class

Class II

Status

Terminated

Initiated by the company

Nov 18, 2013

Posted by the FDA

Nov 26, 2013

Recalling firm

Medtronic Neurosurgery

Quantity

288 units total (147 units in US)

Product code

JXG

FDA submissions

K792005, K792007, K841442

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to US and worldwide: Austria, Belgium, Bosnia, Herzegovina, Canada, Croatia, Germany, Japan, Poland, Portugal, Taiwan, United Arab Emirates, United Kingdom.

Product description

CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, Catalog No. 46026. CSF-Unitized Shunt Kits are designed as integrated CSF-Flow Control Shunts for use in shunting cerebrospinal fluid from the lateral ventricle of the brain into the peritoneal cavity.

Other devices under the same FDA submission

38 devices cleared under K792005, K792007, K841442 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• N/A 43103

  Medtronic Ps Medical, Inc. · Shunt, central nervous system and components
  32 reports
• NA 41101

  Medtronic Ps Medical, Inc. · Shunt, central nervous system and components
  22 reports
• NA 43103

  Medtronic Ps Medical, Inc. · Shunt, central nervous system and components
  19 reports
• NA 42544

  Medtronic Ps Medical, Inc. · Shunt, central nervous system and components
  16 reports
• N/A 41101

  Medtronic Ps Medical, Inc. · Shunt, central nervous system and components
  14 reports
• N/A 22011 M

  Medtronic Ps Medical, Inc. · Shunt, central nervous system and components
  10 reports
• N/A 42544

  Medtronic Ps Medical, Inc. · Shunt, central nervous system and components
  9 reports
• NA 42542

  Medtronic Ps Medical, Inc. · Shunt, central nervous system and components
  6 reports
• NA 43103

  Medtronic Ps Medical, Inc. · Shunt, central nervous system and components
  5 reports
• NA 9003 E

  Medtronic Ps Medical, Inc. · Shunt, central nervous system and components
  5 reports
• NA 43522

  Medtronic Ps Medical, Inc. · Shunt, central nervous system and components
  5 reports
• N/A 42534

  Medtronic Ps Medical, Inc. · Shunt, central nervous system and components
  5 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 66882).

• Z-0398-2014 · Terminated
  Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ve…
• Z-0399-2014 · Terminated
  Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles …