FDA Device recall Z-0900-2014
Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R
- FDA Device
- Class II
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class II recall of Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R by Boston Scientific, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0900-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-06 |
| Published | 2014-02-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Product number: H749364560, Catalog number: 36456; Lot numbers: 16159358, 16183964, 16230195, 16230673, 16247263, 162…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0900-2014%22
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