Z-0667-2007

Disposable components of the superDimension Bronchus System: Locatable Guide Kit (AKI00017-01) and Extended...

Name: Z-0667-2007 Disposable components of the superDimension Bronchus System: Locatable Guide Kit (AKI00017-01) and Extended...
Creator: SuperDimension, Inc.
Published: 2006-11-29
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2006-11-29 / Terminated

FDA source

SuperDimension, Inc. began a recall of Disposable components of the superDimension Bronchus System: Locatable Guide Kit (AKI00017-01) and Extended Working Channel (AKI00041-01) on 2006-11-29. The reason FDA records is "The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure in which a...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0667-2007
Status: Terminated
Initiated: 2006-11-29
Posted: 2007-03-29
Terminated: 2008-11-20
Recalling firm: Medtronic, Inc.
Product: Disposable components of the superDimension Bronchus System: Locatable Guide Kit (AKI00017-01) and Extended Working Channel (AKI00041-01).
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure in which a superDimension Bronchus System was used. The biopsy results for the patient were taken from a different area than the confirmed navigation site that was indicated by the system.
FDA root cause: Other
Action: An Urgent Medical Device Field Action letter, dated 11/30/2006, was sent to medical facilities who have the superDimension Bronchus System installed. The letter infoms the facility to immediately stop using the Bronchus System, and move all inventory of the disposable system components to a controlled quarantine area. A superDimension representative will contact the consignees to schedule a time to retrieve the quarantined inventory, at which time a verification form will be completed.
Quantity in commerce: Up to 2,000 each Locatable Guide Kit and Extended Working Channel
Distribution: Worldwide, including USA, Austria, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, South Africa, Spain, Switzerland, Turkey, and United Kingdom.
Product codes and lots: All codes of disposable system components (Locatable Guide and Extended Working Channel).

Product code JAK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)