Medtronic Recalls DLP Extension Line Adapters Due to Packaging Pinholes
Medtronic Perfusion Systems is recalling DLP Extension Line 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 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: The recall is classified as FDA Class II, and the hazard involves a sterile medical device where packaging integrity is compromised, posing a risk of harm without reported injuries.
Plain-English summary
Medtronic Perfusion Systems is recalling DLP Extension Line Adapters, 20 inches in length, which are used to extend cardioplegia lines during cardiopulmonary bypass surgery. The recall is due to the identification of small pinholes in a single packaging configuration of sterile pouches.
The recall affects a total of seven different products. The specific model number is 11001G, and the affected lot numbers include 2016020769, 2016030796, 2016040778, 2016060872, 2016061425, 2016070500, 2016081190, 2016090516, 2016091016, 2016110504, 2016120414, 2017010236, 2017011281, and 2017030506. The total quantity involved is 63,053 units, with 48,180 units in the US and 14,873 units outside the US.
The products were distributed worldwide, including nationwide in the US and in various foreign countries such as Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Denmark, El Salvador, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Macedonia, Moldova, Netherlands, New Zealand, Nigeria, Norway, Poland, Romania, Russian Federation, Slovenia, Spain, Thailand, Turkey, and the United Kingdom. Healthcare facilities and consumers should stop using the affected products and contact Medtronic Perfusion Systems for further instructions.
The recalled product
- Product
- DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery
- Manufacturer
- Medtronic Perfusion Systems
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 (16)
- Model No. 11001G
- Product UPN 20613994918554
- Lot No. 2016020769
- 2016030796
- 2016040778
- 2016060872
- 2016061425
- 2016070500
- 2016081190
- 2016090516
- 2016091016
- 2016110504
- 2016120414
- 2017010236
- 2017011281
- 2017030506.
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.
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