Z-0900-2014Class II

Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation

Name: Z-0900-2014 Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation
Creator: Boston Scientific Corporation
Published: 2014-01-06
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2014-01-06 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging... on 2014-01-06. FDA classified it as Class II and gives the reason as "Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging catheter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0900-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-06
Posted: 2014-01-30
Terminated: 2014-10-29
Recalling firm: Boston Scientific Corporation
Product: Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035 guidewire.
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging catheter.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Boston Scientific sent an Urgent Medical Device Recall Removal letter dated January 14, 2014 to all affected customers by overnight mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete an Account Reply verification Tracking Form in order to received a Return Goods Authorization number for product return. For questions contact your local Sales Representative.
Quantity in commerce: 1068 single units
Distribution: US Nationwide Distribution and Mexico
Product codes and lots: Product number: H749364560, Catalog number: 36456; Lot numbers: 16159358, 16183964, 16230195, 16230673, 16247263, 16257809, 16268498, 16289177, 16311356, 16330543, 16342824, 16419885, 16420624, 16420903, 16447744, 16458536, 16486133, 16494530; Expiration Date: June 11th 2014 to October 29th 2014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0900-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0900-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)