DLP Left Heart Vent Catheters recalled due to potential wire protrusion
Medtronic is recalling 51,494 DLP Left Heart Vent Catheters due to potential wire protrusion through the catheter tip. This defect could compromise proper device function during use.
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 is an FDA Class II recall. The defect is described as 'potential wire protrusion,' indicating a theoretical hazard without reported injuries or illnesses. The catheter is used in surgical procedures and wire protrusion could compromise device function.
Plain-English summary
Medtronic Perfusion Systems is recalling DLP Left Heart Vent Catheters, 16 FR (Model/Reference Number 12116). The recall involves approximately 51,494 units with expiration dates ranging from September 30, 2020, to May 19, 2024. The catheters were distributed nationwide across the United States and internationally.
The catheters have a potential for wire protrusion through the left heart vent catheter tip. This defect could affect proper device function.
Affected lot numbers have been identified by Medtronic and reported to the FDA. Healthcare providers and facilities should verify their inventory against the affected lot numbers.
The recalled product
- Product
- DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- wire-protrusion
- device-malfunction
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 12116
- Lot Number (GTIN Number): 2018080039 (20643169086719)
- 2018091020 (20643169086719)
- 2018100911 (20643169086719)
- 2018111023 (20643169086719)
- 2018111419 (20643169086719)
- 2019120925 (20643169086719)
- 2018080039 (00673978462943)
- 2018091020 (00673978462943)
- 2018100911 (00673978462943)
- 2018111023 (00673978462943)
- 2018111419 (00673978462943)
- 2018120581 (20643169086719)
- 2018120581 (00673978462943)
- 2018120582 (20643169086719)
- 2018120582 (00673978462943)
- 2018121084 (20643169086719)
- 2018121084 (00673978462943)
- 2019010456 (20643169086719)
- 2019010456 (00673978462943)
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03