Boston Scientific Corporation: Medical Device Recall in 2014 - (Recall #: Z-0900-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: January 6, 2014

Date Posted: February 5, 2014

Recall Number: Z-0900-2014

Event ID: 67298

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.

Status: Terminated

Product Quantity: 1068 single units

Code Information:

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.

Distribution Pattern:

US Nationwide Distribution and Mexico

Voluntary or Mandated:

Voluntary: Firm initiated