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.
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: 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
- Hazard
- wire-protrusion
- injury-risk
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.
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