Z-0837-2009

Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by...

Name: Z-0837-2009 Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by...
Creator: Boston Scientific Corporation
Published: 2008-10-09
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2008-10-09 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by Boston Scientific Corporation, Fremont, CA. Medical... on 2008-10-09. The reason FDA records is "Product is mislabeled as having a shelf life of 3 years, where the actual shelf life is 1 year". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0837-2009
Status: Terminated
Initiated: 2008-10-09
Posted: 2009-01-28
Terminated: 2009-07-27
Recalling firm: Boston Scientific Corporation
Product: Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by Boston Scientific Corporation, Fremont, CA. Medical device, intended for ultrasound examination of peripheral pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: Product is mislabeled as having a shelf life of 3 years, where the actual shelf life is 1 year.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Recall initiated on October 6, 2008, and notification letters sent on October 8, 2008. Letters were sent via FedEx. Responses are being tracked along with delivery verification. For additional information contact Boston Scientific Corporation at 1-508-652-5594.
Quantity in commerce: 1033 units
Distribution: Worldwide Distribution --- USA including Puerto Rico and country of Panama
Product codes and lots: Batch/lot #s 11420600, 11420601, 11420602, 11611665, 11716746, 11720663, 11721240, 11722752, 11727107, 11727873, 11727874, 11728458, 11731354, 11732665, 11735762, 11736559, 11739563, 11742590, 11754455, 11758051, 11764281, 11777994, 11788045, 11790848, 11820112, 11897802, 11897904, and 11904295

Product code ITX

K080272Class IIAtlantis Pvimaging Catheter, Model H749364560Boston Scientific Corp / cleared 2008-03-11

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)