CLASS II Device recall · Reported 25 Jul 2018 · FDA Enforcement Report

Cardica C-Port Flex-A PLUS Distal Anastomosis System recalled by AESDEX

AESDEX is recalling AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, distributed nationwide in the US. The recall was initiated on 2 Apr 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: (01) 1 18 14900 00150 2 Lot numbers: 141118H, 151026C, 151118B, 160205A, 160805A, 160805B, 161128C, 161111D, 170222L, 170322J, 170712A, 170907D, 171201C, 171207C, 180103B.

Quantity recalled400 umits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2434-2018
FDA event ID: 80319
Recalling firm: AESDEX, Redwood City, CA
Classification: Class II
Status: Terminated
Recall initiated: 2 Apr 2018
FDA classified: 13 Jul 2018
Reported: 25 Jul 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Surgical Instruments

Timeline

2 Apr 2018	Recall initiated by company
13 Jul 2018	Classified by FDA	+102 days
25 Jul 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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 create a complete end-to-side anastomosis that is functionally equivalent to a hand-sutured interrupted stitch anastomosis. The system consists of one Anastomosis Device and one Retractor Mount. The system is designed with a flexible shaft to facilitate access to difficult to reach coronary targets.

Where it was distributed

U.S. and international: Belgium, Germany, Italy and Netherlands. No gov accounts.

Nationwide

Stores named: Target

Questions about this recall

Is Cardica C-Port Flex-A PLUS Distal Anastomosis System recalled?

Yes. AESDEX recalled Cardica C-Port Flex-A PLUS Distal Anastomosis System on 2 Apr 2018. The recall is Class II and its status is Terminated. Recall number Z-2434-2018.

Why was it recalled?

Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components.

Which lots are affected?

UDI: (01) 1 18 14900 00150 2 Lot numbers: 141118H, 151026C, 151118B, 160205A, 160805A, 160805B, 161128C, 161111D, 170222L, 170322J, 170712A, 170907D, 171201C, 171207C, 180103B.

Where was it sold?

U.S. and international: Belgium, Germany, Italy and Netherlands. No gov accounts.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from AESDEX

All 2

Reported	Class	Recall	Company	Reason	Where
25 Jul 2018Device	CLASS II	Cardica C-Port xA PLUS Anastomosis System recalled by AESDEX	AESDEX	Foreign Material	Nationwide

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