Agency classClass IIOur severity:High FDA (Devices)·Z-1844-2019·Announced 2019-06-26

Cook Zenith Alpha Abdominal Endovascular Graft Recall for Damaged Safety Lock Knob

Cook Inc. is recalling Zenith Alpha Abdominal Endovascular Grafts that may contain a damaged gray safety lock knob, which could prevent full deployment of the graft.

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 defect that could lead to a prolonged procedure and open surgical intervention, representing a risk of harm where injury has not yet been reported, consistent with a High severity rating.

Plain-English summary

Cook Inc. is recalling 1,027 units of the Zenith Alpha Abdominal Endovascular Graft. The recall is due to a potential defect where the product may contain a damaged gray safety lock knob. This defect could result in difficulty or an inability to fully deploy the graft using the standard or troubleshooting methods provided in the Instructions for Use (IFU).

The product was distributed to foreign countries including Australia, Austria, Belgium, Brazil, Canada, and others, but there was no US distribution. The source text does not specify the exact number of affected units or the specific dates of distribution.

Potential adverse events if an affected product is used include a prolonged procedure and the need for open surgical intervention. Consumers and healthcare providers should check their inventory for the specific reference part numbers and lot codes listed in the official recall notice and contact Cook Inc. for further instructions.

The recalled product

Product: Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84…
Manufacturer: Cook Inc.
Category: Medical Device — Endovascular Graft
Hazard: deployment-failure
surgical-intervention
Affected units: 1,027

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)

9221784
9228731
9232249
9246529
9272685
9272835
9276029
9276400
9303245
9373623
9406776
9466908
9506559
9525188
9557569
9566160
9566211
9575380
9620378
9620379

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Cook Inc.

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Same hazard · deployment failure