AesDex Cardica C-Port xA PLUS Anastomosis System Recalled for Handle Damage
AesDex is recalling 587 Cardica C-Port xA PLUS Anastomosis Systems because the handle mechanism may break during use, causing a loud noise and potential dispersion of plastic fragments.
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 (medical device) where injury has not yet been reported, fitting the High severity criteria for potential physical harm from device failure.
Plain-English summary
AesDex, LLC is recalling 587 units of the Cardica C-Port xA PLUS Anastomosis System, Catalog Number FG-000100. This medical device is used to create an anastomosis between a small target vessel, such as a coronary artery, and a conduit, such as a saphenous vein graft, using stainless steel clips. The system consists of one Anastomosis Device and one Retractor Mount.
The recall is due to a defect where damage to the device handle mechanism may occur following pressurization. This failure is accompanied by a loud noise and the potential dispersion of plastic fragments and components. The affected units were distributed in the United States and internationally to Belgium, Germany, Italy, and the Netherlands. No government accounts were involved in the distribution.
The affected lot numbers are 141031D, 150720K, 160317A, 160722E, 170223E, 170509G, and 171012A. The Unique Device Identifier (UDI) for the product is (01) 1 18 14900 00100 7. Healthcare providers and facilities should stop using these devices and contact AesDex for further instructions on the recall process.
The recalled product
- Product
- AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardica C-Port xA PLUS Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and conduit (e.g. saphenous vein…
- Manufacturer
- AESDEX
- Affected units
- 587
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 (7)
- UDI: (01) 1 18 14900 00100 7. Lot numbers: 141031D
- 150720K
- 160317A
- 160722E
- 170223E
- 170509G
- 171012A.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by AESDEX 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 2 products in this recall →Related recalls
Same manufacturer · AESDEX
See all →- HighAesDex Cardica C-Port Flex-A PLUS Distal Anastomosis System Recalled for Handle Damage
FDA (Devices) · 2018-07-25
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