Medtronic Recalls DLP Femoral Arterial Cannulas Due to Connection Issues
Medtronic is recalling specific lots of DLP Femoral Arterial Cannulas because users reported difficulty connecting the device to perfusion circuit tubing.
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 medical device where a functional defect (inability to connect) poses a risk of harm during a medical procedure, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Medtronic Perfusion Systems is recalling select lots of DLP Femoral Arterial Cannulas and DLP Femoral Cannula Replacement Kits. The affected products include models 57414, 57417, and 57421, as well as replacement kit models 96017 and 96021. These devices are sterilized using Ethylene Oxide and are designed to fit over each other to progressively dilate the vessel during insertion.
The recall was initiated due to recent reports in which users experienced difficulty or were unable to connect the cannula to the perfusion circuit tubing. The cannula and dilator components are made of polyurethane with tapered proximal tips to aid in diameter transition.
A total of 1,304 devices were distributed worldwide, including in the United States and various international countries. Specific lot numbers for each model are listed in the official recall documentation. Users should check their inventory against the provided lot numbers and contact Medtronic for further instructions.
The recalled product
- Product
- Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized using Ethylene Oxide. The cannula and dilator components are polyurethane and have tapered proximal tips to aid in diameter…
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device — Vascular Access
- Affected units
- 1,304
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 (13)
- Model 57414 / Lot Numbers: 2014124994
- 2015016150
- 2015016729
- 2015020381
- 2015021484
- and 201501C886. Model 57417 / Lot Numbers: 2014125438
- 2015016317
- 2015016695
- 2015020566
- 2015021401
- 2015030166
- 2015030435
- 2015030629
Distribution
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