Medtronic Recalls DLP Pressure Monitoring Extension Line Adapters
Medtronic Perfusion Systems is recalling DLP Pressure Monitoring Extension Line Adapters due to small pinholes in sterile packaging.
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 involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Medtronic Perfusion Systems is recalling DLP Pressure Monitoring Extension Line Adapters, which are used to extend pressure lines during cardiopulmonary bypass surgery. The recall affects a total of seven different products.
The recall was initiated because small pinholes were identified in a single packaging configuration of the sterile pouches. This defect could potentially compromise the sterility of the medical devices.
The affected products were distributed worldwide, including nationwide in the United States and in numerous foreign countries. Consumers and healthcare providers should stop using these specific adapters and contact Medtronic Perfusion Systems for further instructions or replacement.
The recalled product
- Product
- DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device — Cardiovascular
- Hazard
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 (19)
- Model No. 25009
- Product UPN 20613994918608
- Lot No. 2016090217
- 2016091068
- 2016100893
- 2016110439
- 2016120464
- 2017010278
- 2017030102
- 2017030576
- 2017031125. Model No. 25010: Product UPN 20613994918585: Lot No. 2016020841
- 2016031522
- 2016050255
- 2016070494
- 2016081243
- 2016090923
- 2016110054
- 2016110837
- 2017040714.
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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