AesDex Cardica C-Port Flex-A PLUS Distal Anastomosis System Recalled for Handle Damage
AesDex is recalling the Cardica C-Port Flex-A PLUS Distal Anastomosis System because the handle mechanism may be damaged during use, potentially causing plastic fragments to disperse.
What this means for you
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 mechanical defect that could cause injury via plastic fragment dispersion, but the source text does not report any actual injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
AesDex, LLC is recalling the Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number FG-000150. This medical device is used to create an anastomosis between a small target vessel and a conduit using stainless steel clips. The system consists of one Anastomosis Device and one Retractor Mount and is designed with a flexible shaft to access difficult-to-reach coronary targets.
The recall is being issued because damage to the device handle mechanism may occur following pressurization. This damage is accompanied by a loud noise and the potential dispersion of plastic fragments and components. The source text does not report any specific injuries or illnesses associated with this defect.
The affected units were distributed in the United States and internationally to Belgium, Germany, Italy, and the Netherlands. The recall covers 400 units across specific lot numbers, including 141118H, 151026C, and 180103B. Healthcare providers and facilities should stop using the affected devices and contact AesDex for instructions on return or replacement.
The recalled product
- Product
- AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The Cardica C-Port Flex-A PLUS Distal Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel and conduit. The stainless steel clips cr
- Manufacturer
- AESDEX
- Affected units
- 400
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 (15)
- UDI: (01) 1 18 14900 00150 2 Lot numbers: 141118H
- 151026C
- 151118B
- 160205A
- 160805A
- 160805B
- 161128C
- 161111D
- 170222L
- 170322J
- 170712A
- 170907D
- 171201C
- 171207C
- 180103B.
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 xA PLUS Anastomosis System Recalled for Handle Damage
FDA (Devices) · 2018-07-25
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