Atlantis PV — Class II medical device recall Z-0900-2014
Terminated recall by Boston Scientific Corporation, reported 2014-02-05, distributed nationwide. Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit p
| Recall number | Z-0900-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Fremont, CA, United States |
| Recall initiated | 2014-01-06 |
| Classified | 2014-01-30 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2014-10-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 1,068 single |
| Lot numbers | 16159358, 16183964, 16230195, 16230673, 16247263, 16257809, 16268498, 16289177, 16311356, 16330543, 16342824, 16419885, 16420624, 16420903, 16447744, 16458536, 16486133, 16494530 |
| Model numbers | 36456 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0900-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.