Medtronic DLP Antegrade/Retrograde Adapter Recalled for Packaging Pinholes
Medtronic is recalling DLP Antegrade/Retrograde Adapters because small pinholes were found in a single packaging configuration of sterile pouches.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a packaging defect (pinholes) that compromises sterility. No specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Medtronic Perfusion Systems is recalling the DLP Antegrade/Retrograde Adapter, a medical device used for the perfusion of cardioplegia in either an antegrade or retrograde fashion. The recall involves a total of seven different products.
The recall was initiated due to the identification of small pinholes in a single packaging configuration of sterile pouches. This defect affects the integrity of the sterile packaging for the affected units.
The affected products were distributed worldwide, including in the United States and numerous foreign countries. Consumers and healthcare providers should stop using the affected products and contact Medtronic Perfusion Systems for further instructions.
The recalled product
- Product
- DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate direct connections to the cannulae
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device — Cardiac Surgery
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 No. 13001
- Product UPN 20613994677611
- Lot No. 2016020795
- 2016030222
- 2016030813
- 2016031019
- 2016040411
- 2016040614
- 201604C004
- 2016050516
- 2016050769
- 2016051176
- 2016060227
- 2016061042
- 2016061440
- 2016070193
- 2016070921
- 2016070922
- 2016080373
- 2016090545
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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 5 products in this recall →Related recalls
Same manufacturer · Medtronic Perfusion Systems
See all →- HighArterial Cannula Recall: EOPA 3D 22FR May Develop Pinhole Leaks During Bypass
FDA (Devices) · 2026-08-05
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- HighArterial Cannula Recalled Due to Risk of Pinhole Leaks During Bypass
FDA (Devices) · 2026-08-05
- HighArterial Cannula Recalled Due to Pinhole Leaks During Cardiopulmonary Bypass
FDA (Devices) · 2026-08-05
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- HighMedtronic Cardioplegia Adapters recalled for potential unsealed sterile packaging
FDA (Devices) · 2024-05-22
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
- HighMedtronic Recalls DLP Femoral Arterial Cannulas Due to Connection Issues
FDA (Devices) · 2015-07-08
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic Arterial Cannulae Recalled Due to Unsealed Sterile Packaging
FDA (Devices) · 2024-05-22