Abbott Vascular Recalls Armada 35 PTA Catheters Due to Inflation Issues
Abbott Vascular is recalling Armada 35 and Armada 35 LL PTA Catheters because some devices may have difficulty inflating or deflating.
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 with a functional defect (difficulty inflating/deflating) that poses a risk of harm during use, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters. These medical devices are intended for the dilatation of lesions in the vasculature. The recall involves 61,799 units that were distributed nationwide in the United States and in Puerto Rico.
The recall was initiated because the manufacturer discovered that some of the devices may exhibit difficulty inflating and/or deflating. This functional defect could impact the intended use of the catheter during medical procedures.
Healthcare providers and patients should check their inventory and records for the specific lot numbers listed in the official recall notice. If a device is found to be affected, it should be removed from use and returned to Abbott Vascular according to their instructions.
The recalled product
- Product
- Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
- Manufacturer
- Abbott Vascular
- Hazard
- Affected units
- 61,799
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)
- U.S. Lot #: 737538
- 737576
- 738162
- 738486
- 738641
- 739286
- 739518
- 739837
- 740078
- 740090
- 740306
- 740310
- 740575
- 740579
- 740583
- 740591
- 740599
- 740824
- 740828
- 740832
Distribution
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