The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2505-2021·Announced 2021-09-29

DLP Left Heart Vent Catheters Recalled for Potential Wire Protrusion

Medtronic recalls DLP Left Heart Vent Catheters due to risk of wire protrusion through the catheter tip. The defect could cause internal injury during cardiac procedures.

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: This FDA Class II recall involves a mechanical defect (wire protrusion) in a high-risk cardiac device that creates potential for internal injury. No illnesses or injuries are reported in the source text, and the hazard is theoretical. This meets the rubric criterion of 'risk-of-harm products where injury has not yet been reported,' corresponding to score 3 (High).

Plain-English summary

Medtronic Perfusion Systems is recalling DLP Left Heart Vent Catheters, 18 FR (model 12118), due to a potential defect in catheter tip design that could allow a wire to protrude.

These catheters are sterile devices used during cardiac procedures for left heart venting. Wire protrusion from the catheter tip could cause internal tissue injury during use.

Approximately 48,672 units have been distributed nationwide within the United States and internationally. The recall affects multiple lot numbers with expiration dates ranging from September 30, 2020 through May 19, 2024. Healthcare facilities that have received these catheters should cease use immediately and contact Medtronic Perfusion Systems for guidance on product return or replacement.

The recalled product

Product
DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Cardiac / Left Heart Device
Hazard
Affected units
48,672

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)

  • Model/Reference Number 12118
  • Lot Number (GTIN Number): 2018080452 (20643169086702)
  • 2018080452 (00673978462950)
  • 2018090435 (20643169086702)
  • 2018090435 (00673978462950)
  • 2018100525 (20643169086702)
  • 2018100525 (00673978462950)
  • 2018111024 (20643169086702)
  • 2018111024 (00673978462950)
  • 2018111421 (20643169086702)
  • 2018111421 (00673978462950)
  • 2019020369 (20643169086702)
  • 2019020369 (00673978462950)
  • 2019030426 (20643169086702)
  • 2019030426 (00673978462950)
  • 2019031168 (20643169086702)
  • 2019031168 (00673978462950)
  • 2019041190 (20643169086702)
  • 2019041190 (00673978462950)
  • 2019060424 (20643169086702)

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Medtronic Perfusion Systems 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 2 products in this recall →

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