The Recall Desk
HighFDA (Devices)·Z-1116-2021·Announced 2021-02-24

Medtronic Recalls Cerebrospinal Fluid Valves Due to Radiopaque Marking Issues

Medtronic Neurosurgery is recalling 22,528 units of STRATA II cerebrospinal fluid valves and shunts worldwide because radiopaque markings may vary in visibility under imaging.

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: The recall is classified as FDA Class II. The hazard involves a potential defect in radiopaque markings that could affect medical imaging, representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Medtronic Neurosurgery is recalling 22,528 units of STRATA II cerebrospinal fluid flow control valves and shunts. The recall covers specific catalog numbers (CFNs) including 27739, 27740, 27812, and others, distributed worldwide to numerous countries including the United States, Canada, and various nations in Europe, Asia, and the Americas.

The recall is issued due to a potential for variation in the visibility of radiopaque markings on these adjustable and fixed-pressure valves. These markings are used to identify the device under radiographic imaging in the management of hydrocephalus. The source text does not report any illnesses, injuries, or deaths associated with this defect.

Healthcare providers and patients with these specific devices should contact Medtronic Neurosurgery for instructions on how to proceed. The recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHUNT 27740 STRATA NSC SNAP REG 120CM, 27812 - VALVE 27812 STRATA II SM EXTRACTED, 27814 - SHUNT 2781
Manufacturer
Medtronic Neurosurgery
Category
Medical Device — Neurosurgery
Hazard
Affected units
22,528

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)

  • Lot numbers for the affected CFNs: 0219498492
  • 0219471229
  • 0218700308
  • 0219498495
  • 0220423969
  • 0219378043
  • 0219802947
  • 0219395919
  • 0219395920
  • 0219395921
  • 0219471351
  • 0219470063
  • 0219470064
  • 0219471352
  • 0219127878
  • 0219127879
  • 0219127880
  • 0219550965
  • 0219551126
  • 0219551128

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Medtronic Neurosurgery under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Medtronic Neurosurgery

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Same hazard · imaging visibility

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